Medtronic Recalls Suction and Anticoagulation Assemblies Due to Connector Defects
Medtronic is recalling 7,587 Suction and Anticoagulation Assemblies because Y-connectors may tear or crack, potentially causing leaks and blood loss.
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 is classified as FDA Class II, and the source describes a risk-of-harm product (potential blood loss and circuit breach) where no specific injuries or illnesses have been reported yet, fitting the 'High' severity criteria.
Plain-English summary
Medtronic Perfusion Systems is recalling 7,587 units of Suction and Anticoagulation Assemblies (models BTC93 and BTC98). These medical devices are indicated for use with an autotransfusion system, specifically connecting the suction tip and the 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. Users should check their inventory for the specific lot and serial numbers listed in the official recall notice and contact Medtronic Perfusion Systems for instructions on how to return or replace the affected units.
The recalled product
- Product
- SUCTION / ANTICOAGULATION ASSEMBLY (a) BTC93 (b) BTC98 Suction and Anticoagulation assemblies are indicated for use with an autotransfusion system between the suction tip and reservoir.
- Manufacturer
- Medtronic Perfusion Systems
- Affected units
- 7,587
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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