Reprocessed Medtronic Marinr Steerable Electrophysiology Catheter Recall
Stryker Sustainability Solutions is recalling 87 units of the Medtronic Marinr Steerable reprocessed electrophysiology catheter (Product Number 72402) due to incomplete seals on the sterile product.
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 compromised sterility assurance, which presents a risk of harm. Although no reported illnesses or injuries are stated in the source, the potential for infection or contamination due to incomplete seals on a sterile surgical instrument constitutes a high-risk situation that meets the High severity threshold.
Plain-English summary
Stryker Sustainability Solutions is recalling 87 units of the Medtronic Marinr Steerable reprocessed electrophysiology catheter, Product Number 72402, across the United States, Israel, and Canada. The affected catheters were distributed with incomplete seals on the sterile product, which may compromise sterility assurance.
The incomplete seals create a risk that the sterile integrity of the product may be compromised. This could potentially affect the safety and effectiveness of the device during clinical use.
Patients and healthcare providers who have received or used this product should contact their hospital or clinic for guidance. The affected lot numbers are: 4147881, 4760091, 4848398, 4966192, 4995002, 5022496, 5053580, 4470118, 4778468, 4848976, 4966193, 4999115, 5029362, 5063586, 4490754, 4796800, 4855294, 4966194, 5002565, 5029363, 5068369, 4509009, 4815121, 4866012, 4966195, 5002566, 5029364, 5076464, 4527883, 4815122, 4874149, 4969132, 5002873, 5029535, 5085337, 4655115, 4820151, 4883354, 4973129, 5009392, 5029698, 5085818, 4720484, 4826777, 4890964, 4981099, 5014818, 5032181, 4730762, 4845060, 4940777, 4982418, 5017600, 5032182, 4754876, 4846853, 4941142, 4987516, 5018180, 5039989, 4758759, 4847494, 4948941, 4989050, 5018181, 5044865. The UDI is UDI00885825011260.
The recalled product
- Product
- Medtronic Marinr Steerable, Product Number 72402; REPROCESSED ELECTROPHYSIOLOGY CATHETER
- Manufacturer
- Stryker Sustainability Solutions
- Affected units
- 87
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)
- UDI00885825011260
- Lot Numbers: 4147881
- 4760091
- 4848398
- 4966192
- 4995002
- 5022496
- 5053580
- 4470118
- 4778468
- 4848976
- 4966193
- 4999115
- 5029362
- 5063586
- 4490754
- 4796800
- 4855294
- 4966194
- 5002565
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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