Class II U.S. Food and Drug Administration

Thoratec LLC CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016 recall: Acute circulatory support system pump may not fit into the motor and reports

Recall published 9 months ago

Acute circulatory support system pump may not fit into the motor and reports received of the pump not being securely locked into the motor using the screw-in locking feature. Failure to properly lock the pump into motor my not cause pump not inserted alarm, and could lead to particulate, increased heat, anxiety, inconvenience, delay in hemodynamic/ECMO support, stroke, embolism, death.

The hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

What the notice says: Acute circulatory support system pump may not fit into the motor and reports received of the pump not being securely locked into the motor using the screw-in locking feature. Failure to properly lock the pump into motor my not cause pump not inserted alarm, and could lead to particulate, increased heat, anxiety, inconvenience, delay in hemodynamic/ECMO support, stroke, embolism, death.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-1099-2026
Published
January 21, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Thoratec LLC
Product type
Medical devices
Units affected
8399
Distribution
Nationwide
Made in
United States
Lot / code info
UDI-DI: 07640135140627, 07640135140603, 05415067036414 IFU: Part(Name) Revision: For US: 1. ARTEN600254920 (IFU CentriMag Blood Pump ABT) Rev C 2. ARTEN600254958 (IFU PediMag Blood Pump US ABT) Rev C 3. ARTEN100174794 (CentriMag Adult Pre-connected Pack IFU, US) Rev B 4. ARTEN600230157 (IFU CentriMag Blood Pump ECMO US) Rev D FOR OUS: ARTEN600254935 (IFU CentriMag Blood Pump CAN ABT) Rev C ARTEN600254936 (IFU PediVas Blood Pump Canada ABT) Rev C ARTEN600332205 (IFU CMag VAS-ECMO Pump OUS) Rev A ARTEN600332207 (IFU PVAS VAS-ECMO Pump OUS) Rev A REF 201-20003, 104318, 201-51006, 201-51007, 201-90001 201-90001T don't have associated un-expired batches/serial numbers. REF/Batch(Serial): 102953/10007334, 10007335, 10007336, 10012012, 10012013, 10012014, 10012015, 10012016, 10036179, 10036180, 10036181, 10037990, 10037992, 10037993, 10037995, 10037996, 10046028, 10046029, 10046030, 10046031, 10046032, 10046033, 10058754, 10058755, 10058756, 10061673, 10061675, 10061676, 10061677, 10065946, 10065947, 10065954, 10065955, 10065956, 10071358, 10071359, 10071361, 10073780, 10073781, 10073783, 10082053, 10082055, 10103208, 10103209, 10106345, 10106346, 10106347, 10106348, 10120074, 10120075, 10120076, 10120077, 10122157, 10122158, 10122159, 10125562, 10125563, 10125564, 10125565, 10138336, 10138337, 10138338, 10138339, 10145124, 10145125, 10145126, 10145127, 10164040, 10164041, 10164044, 10168193, 10168194, 10168195, 10168196, 10168197, 10168199, 10168200, 10168201, 10168202, 10168203, 10173214, 10173215, 10206751, 10206752, 10206754, 10211194, 10211195, 10211196, 10211198, 10211199, 10214967, 10214968, 10214969, 10214970, 10214971, 10235009, 10235014, 10235019, 10235024, 10245539, 10245540, 10245541, 10245542, 10245543, 10256365, 10256366, 10289217, 10289218, 10291590, 10291591, 10301036, 10301037, 10301038, 10301039, 10301040, 10301041, 10301042, 10301043, 10301044, 10303473, 10303476, 10303477, 10303478, 10325561, 10341677, 10342238 10343635, 10343636, 10343637, 10343638, 10343639, 10343640, 10351700, 10351701, 10351702, 10351703, 10351704, 10351707, 10359524, 10359525, 10359526, 10359527, 10359528, 10359529, 10359530, 10359531, 10359532, 10371222, 10371223, 10371224, 10371225, 10371226, 10373595, 10373596, 10373597, 10373598, 10373599, 10391563, 10391564, 10391565, 10391566, 10398007, 10398008, 10398009, 10398010, 10398011, 10399853, 10399854, 10399855, 10399856, 10399857, 10399858, 10399859, 10399860, 10399861, 10399862, 10399866, 10399867, 10410026, 10410027, 10410028, 10410197, 10410198, 10410199, 10411641, 10411642, 10414322, 10414323, 10414324, 10414325, 10414326, 10416065, 10416066, 10416067, 10418871, 10419212, 10424524, 10428901, 10428902, 10428904, 10428905, 10428906, 10456505, 10456506, 10456507, 10456508, 10456509, 10457499, 10457500, 10457502, 10464083, 10464085, 10464086, 10464092, 10498116, 10498117, 10498118, 10517215, 10518978, 10518979, 10518980, 10518981, 10518982, 10528585, 10528587, 10528588, 10530704, 10530705, 10530706, 10535290, 10535294, 10535297, 10535299, 10535300, 10535302, 10541032, 10541033, 10541034, 10541035, 10543873, 10543874, 10550324, 10550325, 10550326, 10550328, 10550329, 10560628, 10560629, 10560630, 10567320, 10567321, 10567322, 10567323, 10571084, 10571085, 10571086, 10571087, 10571088, 10571090, 10588824, 10588825, 10588826, 10591390, 10591391, 10591392, 10591393, 10602157, 10602160, 10602161, 10602162, 10602163, 10602164, 10623578, 10623579, 10623581, 10623582, 10623583, 10632619, 10632625, 10632630, 10639955, 10639956, 10639957, 10639959, 10639960, 10646446, 10646447, 10646449, 10646450, 10646451, 10646452, 10650250, 10650251, 10652470, 10652471, 10652472, 10652473, 10652474, 10652475, 10652477, 10652479, 10659763, 10659764, 10663359, 10663361, 10663363, 10670118, 10670122, 10670123, 10670124, 10671920, 10671921, 10671922, 10671923, 10671925, 10680535, 10680536, 10680538, 10680539, 10680540, 10683369, 10683370, 10683371, 10683372, 10688155, 10688156, 10688157, 10688158, 10688159, 10688160, 1…
UPC codes
07640135140627, 07640135140603, 05415067036414

Products covered by this recall

CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016; CentriMag RVAD HDE KIT, REF: 104318; CentriMag Pre-connected Pack, REF: CMAEK00; CentriMag VAD KIT, REF: 201-51006, 201-51007, 201-90001 201-90001T; Blood Pump with CentriMag Acute Circulatory Support System for ECMO, REF: CMAEK01. CentriMag Blood Pump is a component to be used with CentriMag Acute Circulatory Support System

Check your product

The notice names 14 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 07640135140627
  • 07640135140603
  • 05415067036414

Model or item number

On the rating label, the box or the instruction sheet.

  • 102953
  • 201-20003
  • 201-90010
  • 201-90016
  • 104318
  • CMAEK00
  • 201-51006
  • 201-51007
  • 201-90001 201-90001T
  • 201-90001

Serial number

On the rating plate, often next to the date of manufacture.

  • s. REF

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Thoratec LLC — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Report device problems to the FDA through MedWatch.
  3. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  4. Ask the supplier or clinic that provided it what the remedy is in your case.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Company contact: Thoratec LLC — 6035 Stoneridge Dr, Pleasanton, CA, 94588-3270

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Thoratec LLC medical devices recalled?

Acute circulatory support system pump may not fit into the motor and reports received of the pump not being securely locked into the motor using the screw-in locking feature. Failure to properly lock the pump into motor my not cause pump not inserted alarm, and could lead to particulate, increased heat, anxiety, inconvenience, delay in hemodynamic/ECMO support, stroke, embolism, death. Acute circulatory support system pump may not fit into the motor and reports received of the pump not being securely locked into the motor using the screw-in locking feature. Failure to properly lock the pump…

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 07640135140627, 07640135140603, 05415067036414; model number 102953, 201-20003, 201-90010. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Where was the recalled product sold?

It was distributed nationwide.

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