Medtronic Recalls Reservoir Y Adapters Due to Tearing and Cracking
Medtronic is recalling 1,100 Reservoir Y Adapters because the Y-connectors may tear or crack, potentially causing blood loss and circuit breaches during autotransfusion.
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: The recall involves a medical device defect that could result in blood loss and a circuit breach, representing a risk of harm where injury has not yet been reported, which aligns with the High severity criteria.
Plain-English summary
Medtronic Perfusion Systems is recalling 1,100 units of Reservoir "Y" Adapters (models BT920 and BT926). These suction and anticoagulation assemblies are indicated for use with an autotransfusion system between the suction tip and reservoir.
The recall was initiated because Medtronic discovered that certain Y-connectors included in the suction lines have exhibited tearing and cracking. These defects could cause the Y-connectors to leak when in use, which could result in potential blood loss and a breach in the circuit.
The affected products were distributed worldwide, including nationwide in the United States and in Australia, Canada, France, Germany, Japan, and Sweden. Specific lot and serial numbers are listed in the agency's recall record. Users should stop using the affected devices and contact Medtronic Perfusion Systems for instructions on return or replacement.
The recalled product
- Product
- RESERVOIR "Y" ADAPTER, (a) BT920 (b) BT926 Suction and Anticoagulation assemblies are indicated for use with an autotransfusion system between the suction tip and reservoir.
- Manufacturer
- Medtronic Perfusion Systems
- Affected units
- 1,100
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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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