DLP® 31002Recalls & reported problems
Medtronic, Inc. · CANNULA 31002 ARTERIOTOMY 2MM 1.3 20P 17 · Class 2
Data updated Oct 13, 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 20613994575337), received between Sep 12, 2024 and Sep 12, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Crack” (1 report).
3 other recalls cover devices cleared under the same FDA submission (K810820); 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Crack1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 12, 2024Crack; Crack
MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A DLP ARTERIOTOMY CANNULA, IT WAS REPORTED THAT THE TIP BROKE OFF THE 2 MM VESSEL CANNULA DURING VEIN HARVESTING DURING THE CORONARY ARTERY BYPASS GRAFT (CABG) PROCEDURE. WHILE CHECKING THE VEIN AT THE END OF THE BACK TABLE, THE CUSTOMER NOTICED THAT THE TIP CAME OFF THE 2 MM VESSEL CANNULA AND BOUNCED OFF THE TABLE AWAY FROM THE OPERATIVE FIELD. THIS WAS IMMEDIATELY RAISED BY THE CIRCULATING TEAM AND THE SURGEON. THE ENTIRE ROOM WAS SEARCHED MULTIPLE TIMES AND AFTER THOROUGHLY SEARCHING THE ROOM, THE BROKEN PIECE WAS LOCATED BY THE PERFUSIONIST. FOR REFERENCE, THE PIECE WAS NO LARGER THAN A GRAIN OF RICE. THE CUSTOMER STATED THAT IT WAS POSSIBLY DUE TO A DEFECTIVE DEVICE AS THE TIP SHOULD NEVER COME APART FROM THE CANNULA. THE USE OF THE DEVICE WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20199381 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K810820. One submission often covers many models, so check the product and lot details in each record.
- Z-1799-2024 · Mar 19, 2024 · Open, ClassifiedMedtronic Vessel Cannulae: a) DLP 2 mm Vessel Cannula Blunt Tip, Model Number 30004; b) DLP 3 mm Vessel Cannula Blunt Tip, Model Number 30003
- Z-1796-2024 · Mar 19, 2024 · Open, ClassifiedMedtronic I.M.A. Cannulae: DLP 1 mm Arteriotomy Cannula, Model Number 31001
- Z-1316-2024 · Feb 7, 2024 · Open, ClassifiedMedtronic DLP Vessel Cannula, Model Number REF 30000
Other CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS devices
- DLP™ 77010Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass1 recall154 reports
- EOPA™ 77422Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls19 reports
- DLP™ 77008Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls9 reports
- NA HY11W65R1Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls8 reports
- DLP® 12113Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls6 reports
- DLP® Aortic Root Cannula with Flow-Guard™ 11012Medtronic, Inc. · CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS2 recalls5 reports
- EOPA™ 77622Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls4 reports
- NA HY2V10R33Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls3 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page