Becker® 27609Recalls & reported problems
Medtronic Ps Medical, Inc. · BECKER 27609 W/NEEDLESLESS INJ. SITE · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000333485), received between Feb 2, 2024 and Aug 22, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Disconnection” (2 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Nov 1, 2024Open, Classified
Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS).
Z-0661-2025 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Disconnection2
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 22, 2024Disconnection; Disconnection
MEDTRONIC RECEIVED INFORMATION, REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED, THAT THE LINE SEPARATED FROM BELOW THE DRIP CHAMBER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20026847 ↗MalfunctionFeb 2, 2024Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak
MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THERE WAS A DISCONNECTION, AND IT WAS DISCOVERED WHEN THE NURSE ENTERED THE ROOM READY TO DRAIN THE SYSTEM AND NOTICED LEAKING AT THE TUBING AROUND THE BASE OF THE COLLECTION CHAMBER. THE SYSTEM WAS REPLACED WITH ANOTHER ONE. THE PATIENT'S STATUS WAS ALIVE-NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18632184 ↗
Other Device, monitoring, intracranial pressure devices
- Exacta™ 27666Medtronic Ps Medical, Inc. · Device, monitoring, intracranial pressure1 recall124 reports
- Exacta™ 46705Medtronic Ps Medical, Inc. · Device, monitoring, intracranial pressure1 recall117 reports
- CereLink™ 826850Integra Lifesciences Production Corporation · Device, monitoring, intracranial pressure1 recall2 deaths112 reports
- Duet® 46913Medtronic Ps Medical, Inc. · Device, monitoring, intracranial pressure1 recall58 reports
- Becker® 26040Medtronic Ps Medical, Inc. · Device, monitoring, intracranial pressure1 recall46 reports
- CereLink™ 826851Integra Lifesciences Production Corporation · Device, monitoring, intracranial pressure96 reports
- Becker® 46129Medtronic Ps Medical, Inc. · Device, monitoring, intracranial pressure1 recall29 reports
- Codman Microsensor® 826631Integra Lifesciences Production Corporation · Device, monitoring, intracranial pressure75 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.