The Recall Desk
HighFDA (Devices)·Z-1043-2022·Announced 2022-05-18

Medtronic IN.PACT AV Balloon Catheter: Damaged Packaging May Affect Sterility

Medtronic is recalling IN.PACT AV paclitaxel-coated balloon catheters because packaging damage may result in loss of sterility. The devices were distributed worldwide and in the United States.

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 with no reported illnesses or injuries. The hazard (loss of sterility from packaging damage) presents a risk of infection for a vascular medical device, meeting the criterion for High severity where risk-of-harm has been identified but injury has not yet been reported.

Plain-English summary

Medtronic Vascular, Inc. is recalling the IN.PACT AV Paclitaxel-coated PTA Balloon Catheter (Model Reference: IAV06008008P) due to damaged packaging that may result in loss of sterility. Lot number 0010990608 is affected.

Packaging damage can compromise the sterility of the device. Loss of sterility presents a risk of infection or contamination when the device is used in vascular procedures.

The recalled devices were distributed worldwide to numerous countries and across all 50 U.S. states, Puerto Rico, and Washington, D.C. A total of 3 units were included in this recall.

The recalled product

Product
Medtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter, REF: IAV06008008P, Sterile EO, Rx Only
Manufacturer
Medtronic Vascular, Inc.
Category
Medical Device — Cardiovascular / Vascular Access Device
Hazard
  • sterility-loss
  • packaging-damage

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 (1)

  • Lot Number: 0010990608/ GTIN: 00763000232580

Distribution

Distributed nationwide across the United States.

Related recalls

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