BARD EP XT Steerable Reprocessed Electrophysiology Catheter Recall
Stryker Sustainability Solutions is recalling BARD EP XT Steerable reprocessed electrophysiology catheters due to incomplete seals on sterile product, which may compromise sterility. Affected units were distributed in the US, Israel, and Canada.
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 involving a sterile medical device with a barrier compromise defect (incomplete seals) that poses a risk of infection/contamination. Although no illnesses or injuries are reported in the source text, the potential for serious harm from a compromised sterile barrier on an invasive device warrants a High severity rating per the rubric.
Plain-English summary
Stryker Sustainability Solutions is recalling BARD EP XT Steerable, Product Number 200794, reprocessed electrophysiology catheters (UDI 00885825003739) due to incomplete seals on the sterile product. A total of 44 units across multiple lot numbers have been identified with this defect.
The incomplete seals may compromise the sterile barrier of the product, potentially exposing it to contamination. This defect could affect the safety and effectiveness of the catheter when used in electrophysiology procedures.
The affected units were distributed nationwide in the United States, as well as in Israel and Canada. Lot numbers affected include 4573219, 4869696, 4992244, 4999900, 5025367, 5038410, 5085389, 4804556, 4971805, 4992245, 4999902, 5032111, 5043783, 4804558, 4971806, 4992246, 5012684, 5032112, 5043784, 4809474, 4990763, 4992247, 5012708, 5032113, 5043785, 4829451, 4990764, 4993772, 5012709, 5033926, 5043787, 4835199, 4990769, 4997966, 5012711, 5033927, 5056579, 4841812, 4992243, 4998135, 5012726, 5033928, and 5056828.
Healthcare facilities and individuals who have these catheters should stop use and contact Stryker Sustainability Solutions or their healthcare provider for instructions on return or replacement.
The recalled product
- Product
- BARD EP XT Steerable, Product Number 200794; REPROCESSED ELECTROPHYSIOLOGY CATHETER
- Manufacturer
- Stryker Sustainability Solutions
- Affected units
- 44
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 (20)
- UDI 00885825003739
- Lot Numbers 4573219
- 4869696
- 4992244
- 4999900
- 5025367
- 5038410
- 5085389
- 4804556
- 4971805
- 4992245
- 4999902
- 5032111
- 5043783
- 4804558
- 4971806
- 4992246
- 5012684
- 5032112
- 5043784
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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Similar recalls
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