The Recall Desk
Agency classClass IIOur severity: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.

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: 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
Affected units
3

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.

The notice also names 49 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Medtronic Vascular, 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.

See all 2 products in this recall →

Related recalls

Same manufacturer · Medtronic Vascular, Inc.

See all →

Same hazard · sterility loss

See all →

Similar recalls