The Recall Desk
HighFDA (Devices)·Z-0921-2022·Announced 2022-04-20

Abbott Vascular 20/30 Indeflator Recalled for Leaks and Connection Failures

Abbott Vascular recalls 20/30 Indeflator medical devices due to increased complaints of leaks and loose connections. The recall affects 17 product lots distributed nationwide and internationally.

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 medical device recall. The hazard (leaks and loose connections) represents device malfunction with risk of clinical failure, but no reported illnesses or injuries are stated. This qualifies as a risk-of-harm product where injury has not yet been reported, consistent with High severity.

Plain-English summary

Abbott Vascular issued a Class II recall of its 20/30 Indeflator devices (Reference 1000184) due to an increase in complaints regarding leaks and intermittent or loose connections affecting device performance.

The recall involves 17 lots distributed nationwide across all United States regions, Puerto Rico, the District of Columbia, and internationally across multiple countries. The affected product can be identified using Reference Number 1000184 and Device Identifier (GTIN) 08717648013591.

Hospitals, clinics, and individuals who have received these devices should identify the lot number on their product and cross-reference it with the FDA recall notice to determine if their devices are affected. The complete list of affected lot numbers and additional information is available from the FDA database and Abbott Vascular.

The recalled product

Product
20/30 INDEFLATOR -REF 1000184 WPL2122268-01 (2019-03-01)
Manufacturer
Abbott Vascular
Category
Medical Device
Hazard
  • device-leakage
  • loose-connection

Distribution

Distributed nationwide across the United States.

Related recalls

Same category