Reprocessed Electrophysiology Catheter Recalled for Incomplete Seals
Stryker Sustainability Solutions is recalling BARD Dynamic XT Steerable reprocessed electrophysiology catheters due to incomplete seals on the sterile product, which could compromise sterility.
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: FDA Class II recall of a reprocessed medical device with a sterility-compromising defect (incomplete seals) that creates a risk of harm from potential infection. No reported illnesses are stated in the source, but the hazard is a known failure mode with serious potential consequences.
Plain-English summary
Stryker Sustainability Solutions is recalling BARD Dynamic XT Steerable reprocessed electrophysiology catheters (Product Number 201104) due to incomplete seals on the sterile product. The recall affects 5 units distributed nationwide in the United States as well as in Israel and Canada.
The incomplete seals may compromise the sterility of the product. Affected lot numbers are 4064760, 4336810, 4381356, 4381359, and 4401919 (UDI 00885825003890).
Patients and healthcare providers who have received or used units from the affected lots should contact Stryker Sustainability Solutions or their healthcare provider for guidance on return, replacement, or appropriate clinical management.
The recalled product
- Product
- BARD Dynamic XT Steerable, Product Number 201104; REPROCESSED ELECTROPHYSIOLOGY CATHETER
- Manufacturer
- Stryker Sustainability Solutions
- Affected units
- 5
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 (6)
- UDI 00885825003890
- Lot Numbers: 4064760
- 4336810
- 4381356
- 4381359
- 4401919.
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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