Thousands of reprocessed EP catheters recalled
Stryker Sustainability Solutions, an Arizona-based division of Stryker focused on reprocessing single-use medical devices, has recalled certain lots of several reprocessed electrophysiology (EP) catheters. The recall, which covers more than 8,000 devices overall, was initiated after the company identified incomplete seals due to a process control issue.
According to the U.S. Food and Drug Administration (FDA), this is a Class II recall. This means the agency believes the devices “may cause temporary or medically reversible adverse health consequences.”
Several reprocessed catheters included in this recall
These devices were originally designed and manufactured by a variety of medtech companies. This Class II recall only covers specific lots of reprocessed devices distributed by Stryker Sustainability Solutions.
The devices in question are:
- BARD Dynamic Deca Steerable, Product Number 201101—3,063 units
- Medtronic Marinr Steerable, Product Number 72402—87 units
- BARD Dynamic Tip Steerable, Product Number 200344—28 units
- BARD Dynamic Tip Steerable, Product Number 6DYNTP001—427 units
- BARD Dynamic XT Deca Steerable, Product Number 201102—90 units
- BARD Dynamic XT Steerable, Product Number 201103—no quantity listed
- BARD Dynamic XT Steerable, Product Number 201104—5 units
- BARD EP XT Decapolar Steerable, Product Number 201007—217 units
- BARD EP XT Steerable, Product Number 200794—44 units
- BW Webster Duo-Decapolar, Product Number D728260RT—154 units
- CS Uni-Directional w Auto ID, Product Number D135303—449 units
- CS Uni-Directional w Auto ID, Product Number D135304—816 units
- Daig Livewire Steerable, Product Number 401575—319 units
- Daig Livewire Steerable, Product Number 401581—108 units
- Daig Livewire Steerable, Product Number 401582—19 units
- Daig Livewire Steerable, Product Number 401603—9 units
- Daig Livewire Steerable, Product Number 401652—24 units
- Daig Livewire Steerable, Product Number 401904—1,352 units
- Daig Livewire Steerable, Product Number 401905—107 units
- Daig Livewire Steerable, Product Number 401908—3 units
- BARD Dynamic Tip Steerable, Product Number 200131—61 units
- Daig Livewire Steerable BDB, Product Number 401918—2 units
- Daig Livewire Steerable, Product Number 401932—458 units
- Daig Livewire Steerable, Product Number 401923—3 units
- Daig Livewire Steerable, Product Number 401915—206 units
- Daig Livewire Steerable, Product Number 401914—10 units
Devices impacted by this recall should no longer be used
Stryker has urged customers to quarantine all affected devices and stop using them. Credit will be issued for any returned products. The company also highlighted the importance of communicating about this recall within organizations.
Click here for additional details from the FDA.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.