Reprocessed Electrophysiology Catheter Recalled for Incomplete Seals
Stryker Sustainability Solutions is recalling BARD Dynamic XT Steerable reprocessed electrophysiology catheters (Product Number 201103) due to incomplete seals on the sterile product packaging.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a sterile medical device with a potential contamination hazard (incomplete seals). The source text does not report any illness or injury, but the risk-of-harm nature of compromised sterility in an invasive procedure warrants a High severity rating per the rubric.
Plain-English summary
Stryker Sustainability Solutions is recalling BARD Dynamic XT Steerable reprocessed electrophysiology catheters, Product Number 201103, distributed nationwide in the US and in Israel and Canada. The recall is due to incomplete seals on the sterile product packaging.
Incomplete seals on sterile medical devices can compromise product sterility and potentially allow contamination, which poses a risk during use in electrophysiology procedures.
Affected units are identified by UDI 00885825003876. Consumers and healthcare providers who have received this product should discontinue use and contact Stryker Sustainability Solutions for instructions on return or replacement. Providers should review patient records for any adverse events associated with use of affected units.
The recalled product
- Product
- BARD Dynamic XT Steerable, Product Number 201103, REPROCESSED ELECTROPHYSIOLOGY CATHETER
- Manufacturer
- Stryker Sustainability Solutions
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI 00885825003876
- Lot Numbers: xxxxx
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 26 recalled by Stryker Sustainability Solutions under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 26 products in this recall →Related recalls
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