FDA Device Intelligence
Home › MEDTRONIC, INC. › In.Pact™ 018

In.Pact™ 018

MEDTRONIC, INC. · Model IPU05008013P · UDI-DI 00763000291396

ONU Prescription
0
510(k) clearances
5,888
Adverse events (528 deaths)
1
Recalls
26
Facilities

Description

DCB 018 IPU05008013P D5.0 L080 UL0130

Recalls

DateFirmReason
2022-03-23Medtronic Vascular, Inc.Packaging for Balloon Catheters may be damaged resulting in loss of sterility.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.