Highest risk U.S. Food and Drug Administration

Abbott Coronary dilatation catheters recall: Catheter balloon may not deflate as intended

Recall published 6+ years ago

Catheter balloon may not deflate as intended

The hazard: Device safety concern

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

What the notice says: Potential risks include prolonged cardiac ischemia, air embolism, thrombosis, myocardial infarction and additional intervention, such as surgery that could lead to post-operative complications which include 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

Published
February 20, 2020
Risk level
Highest risk
Issued by
U.S. Food and Drug Administration
Brand
Abbott
Product type
Medical devices
Reports of harm
At the time the FSN was issued, there were no reports of patient death.

Products covered by this recall

Coronary dilatation catheters

What the company announced

Abbott has voluntarily recalled specific lots of two catheters used in coronary angioplasty procedures: the NC Trek RX Coronary Dilatation Catheter and the NC Traveler Coronary Dilatation Catheter, balloon diameters 4.0mm, 4.5mm and 5.0mm. This recall does not affect patients who have successfully undergone cardiac procedures using these devices.

Abbott issued a Field Safety Notice (FSN) on Jan. 29, 2020, to physicians and hospitals who received coronary catheters from the affected lots and is arranging the return and replacement of all remaining products. The affected products were manufactured between July 29, 2019 – Dec. 19, 2019 and distributed between Aug. 16, 2019 – Jan. 3, 2020. The total number of distributed units from identified lots potentially affected is 40,429.

Coronary dilation catheters are used to open clogged blood vessels to improve blood flow to the heart. The balloons from the impacted lots may not deflate as intended. Potential risks include prolonged cardiac ischemia, air embolism, thrombosis, myocardial infarction and additional intervention, such as surgery that could lead to post-operative complications which include death.

The FDA has classified this as a Class I recall. The frequency of reported events that include slow, partial and failure to deflate the balloon, is 0.12 percent worldwide. At the time the FSN was issued, there were no reports of patient death. Since the issuance of the FSN, Abbott has become aware of one reported case in which the inability to deflate the balloon necessitated intervention, which resulted in post-procedural complications leading to a patient death.

Healthcare providers that received the Jan. 29, 2020 FSN are directed to read the document and follow its instructions.

Adverse reactions or quality problems experienced with the use of this product can be reported to Abbott at (800) 227-9902. Reports may also be sent to the FDA's MedWatch Adverse Event Reporting program by completing Form FDA 3500 online at FDA.gov, https://www.fda.gov/safety/medwatch/ , calling 1-800-FDA-1088 of faxing to 1 800 FDA 0178.

—more—

For U.S. Important Safety Information about NC Trek RX, visit https://www.cardiovascular.abbott/us/en/hcp/products/percutaneous-coronary- intervention/nc-trek-coronary-dilation-catheters.html#prodisi

About Abbott

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries.

Connect with us at www.abbott.com , on LinkedIn at www.linkedin.com/company/abbott-/ , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 1 code you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

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

  • 429

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

What to do about Device

Abbott — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  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.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

Remedy named in the notice: Abbott issued a Field Safety Notice (FSN) on Jan. 29, 2020, to physicians and hospitals who received coronary catheters from the affected lots and is arranging the return and replacement of all remaining products.

Company contact: Abbott — Consumers: Abbott, (800) 227-9902 — Media: Alicia Swanson, (408) 845-3427

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 — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Abbott medical devices recalled?

Catheter balloon may not deflate as intended Potential risks include prolonged cardiac ischemia, air embolism, thrombosis, myocardial infarction and additional intervention, such as surgery that could lead to post-operative complications which include death.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 429. 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?

The notice says: Abbott issued a Field Safety Notice (FSN) on Jan. 29, 2020, to physicians and hospitals who received coronary catheters from the affected lots and is arranging the return and replacement of all remaining products.

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