Medtronic Intracoronary Shunts recalled for potential unsealed sterile packaging
Medtronic Intracoronary Shunts may have compromised sterile packaging, potentially allowing contamination. The FDA Class II recall affects 1,410 units distributed worldwide.
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 with no reported illnesses or injuries. The hazard is a potential for unsealed sterile packing that could lead to device contamination, representing a theoretical risk of harm to patients if affected devices were used.
Plain-English summary
Medtronic Perfusion Systems has recalled three models of Medtronic Intracoronary Shunts: the 1.00 mm (Model 31100), 1.25 mm (Model 31125), and 2.00 mm (Model 31200) models. A total of 1,410 units are affected by this recall.
The recall addresses a potential for unsealed sterile packing. If the sterile packaging is not properly sealed, it could be compromised before the device reaches the patient, potentially introducing contamination.
These devices have been distributed worldwide. If you have these devices in inventory, contact Medtronic Perfusion Systems immediately regarding the recall. Healthcare facilities should verify their stock and follow the manufacturer's instructions for proper handling and return of affected units.
The recalled product
- Product
- Medtronic Intracoronary Shunts: a) ClearView¿ 1.00 mm Intracoronary Shunt, Model Numbers: 31100; b) ClearView¿ 1.25 mm Intracoronary Shunt, Model Numbers: 31125; c) ClearView¿ 2.00 mm Intracoronary Shunt, Model Numbers: 31200
- Manufacturer
- Medtronic Perfusion Systems
- Category
- Medical Device — Intracoronary
- Affected units
- 1,410
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 (13)
- a) Model Numbers: 31100
- GTIN 20885074257116
- Lot Numbers: 2023081208
- b) Model Numbers: 31125
- GTIN 20885074257406
- lot Numbers: 2023041455
- 202306C205
- c) Model Numbers: 31200
- GTIN 00885074257433
- Lot Numbers: 2023040542
- GTIN 20885074257437
- 2023041002
- 202305C173
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 13 recalled by Medtronic Perfusion Systems 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.
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