Class II U.S. Food and Drug Administration

Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter recall: The product is defective due to insufficient UV curing of the hydrophilic

Recall published 5 days ago

The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.

The hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

What the notice says: The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.

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-0247-2027
Published
October 28, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Boston Scientific Cork, Ltd.
Product type
Medical devices
Units affected
1349
Distribution
Nationwide
Made in
Ireland
Lot / code info
Material Number: M001195500; UDI-DI: 08714729839576; Batch Numbers: 38061298, 38061299, 38092411, 38092412, 38092413, 38112475, 38112476, 38112477, 38167702, 38167705, 38181964, 38181965, 38181966, 38181967, 38181968, 38416361, 38416362, 38595650, 38595651, 38595652, 38650001, 38650003, 38746409, 38746410, 38810247, 38810248, 38904814, 38904815, 38937266, 38937267, 38937268, 38937270, 38990858, 39027320, 39092275, 39092276, 39092277, 40466592, 40466593, 40471963, 40471964, 40478978, 40478979, 40502334, 40502335, 40504653, 40504654, 40513028, 40513029, 40513030, 40524000;
UPC codes
08714729839576

Products covered by this recall

Direxion Torqueable Microcatheter, NGMC/SINGLE/027/SWAN/1RO/130; Material Number: M001195500

Check your product

The notice names 8 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.

  • 08714729839576

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 38061298
  • 38061299
  • 38092411
  • 38092412
  • 38092413
  • 38112475
  • 38112476

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

Boston Scientific Cork, Ltd. — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: Boston Scientific Cork, Ltd. — Boston Scientific Limited, Business And Technology Park, Model Farm Road, Cork

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 Boston Scientific Cork, Ltd. medical devices recalled?

The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 08714729839576; lot code 38061298, 38061299, 38092411. 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?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Where was the recalled product sold?

It was distributed nationwide.

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