Pump 381 Pump Set lacks labeling for Shockwave catheter interaction risk
Abiomed's Pump 381 Pump Set labeling lacks information about potential interactions with Shockwave Coronary IVL Catheters during coronary interventions. The manufacturer is updating instructions for use to address this gap.
What this means for you
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 device with a potential (unreported) device interaction identified during cardiac interventions. This qualifies as High because it represents a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Abiomed is issuing a recall of the Pump 381 Pump Set to address a labeling deficiency. The device's current labeling lacks information about a potential interaction with the Shockwave Coronary IVL Catheter when used during coronary interventions.
Abiomed has identified that the Instructions for Use (IFU) do not contain guidance about this potential device interaction. The recall is being issued proactively to ensure healthcare providers have complete information before using these devices together.
The recall affects 11,236 units of the Pump 381 Pump Set distributed worldwide, including in the United States, Australia, Austria, Belgium, and multiple other countries. Healthcare providers who use this device during coronary interventions should be aware of this labeling update.
No adverse events or injuries have been reported related to this interaction. Abiomed is updating the device labeling to include information about the potential interaction. Facilities should implement the revised labeling when available, though no device removal or recall of already-distributed units has been requested.
The recalled product
- Product
- Pump 381 Pump Set (US); Product Code: 1000080;
- Manufacturer
- Abiomed, Inc.
- Hazard
- Affected units
- 11,236
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 (2)
- Product Code: 1000080
- UDI-DI: 00813502012279
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 18 recalled by Abiomed, Inc. 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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