BIO-MEDICUS® 96530-017Recalls & reported problems
Medtronic, Inc. · CANNULA 96530-017 BIO-MED ART 17FR 17L · Class 2
All models of Bio-Medicus (59)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994489982), received between May 12, 2017 and May 12, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Misassembled During Manufacturing /Shipping” (1 report).
1 other recall cover devices cleared under the same FDA submission (K884129); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Device Misassembled During Manufacturing /Shipping1
- Disconnection1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 12, 2017Disconnection; Device Misassembled During Manufacturing /Shipping; Disconnection; Device Misassembled During Manufacturing /Shipping
MEDTRONIC RECEIVED INFORMATION THAT DURING UNPACKAGING, THE CUSTOMER OBSERVED THE FITTING WAS NOT CONNECTED TO THE BODY OF THE CANNULA. THE PRODUCT WAS REPLACED WITH ANOTHER AND NOT USED FOR A CASE. THERE WAS NO PATIENT INVOLVEMENT IN THIS PRODUCT ISSUE.
Patient problems: No Patient Involvement
MAUDE report 6564857 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K884129. One submission often covers many models, so check the product and lot details in each record.
- Z-1929-2008 · May 9, 2008 · TerminatedMedtronic Bio-Medicus Percutaneous Cannula & Introducer Set, Catalog Number: CB96535-015
Other CATHETER, PERCUTANEOUS devices
- WATCHMAN FXD Curve™ Access System M635TU80020Boston Scientific Corporation · Catheter, percutaneous1 recall47 deaths654 reports
- NA C315HIS02Medtronic, Inc. · Catheter, percutaneous1 recall369 reports
- WATCHMAN TruSteer™ Access System M635TU90050Boston Scientific Corporation · Catheter, percutaneous1 recall28 deaths302 reports
- Guidezilla™ II H7493933515060Boston Scientific Corporation · CATHETER, PERCUTANEOUS1 recall3 deaths278 reports
- Velocity Delivery Microcatheter VEL160STR-APenumbra, Inc. · CATHETER, PERCUTANEOUS297 reports
- Guidezilla™ H7493924215050Boston Scientific Corporation · CATHETER, PERCUTANEOUS294 reports
- WATCHMAN™ TruSeal™ Access System M635TU70020Boston Scientific Corporation · Catheter, percutaneous1 recall11 deaths217 reports
- Lantern Delivery Catheter PXSLIMLAN135T45Penumbra, Inc. · CATHETER, PERCUTANEOUS220 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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