SJM™ 1314Recalls & reported problems
St. Jude Medical, Inc. · Epideral Needle · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05415067017864), received between Jan 18, 2024 and Jan 18, 2024 — classified as 1 injury.
1 other recall cover devices cleared under the same FDA submission (K053318); 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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Cerebrospinal Fluid Leakage1
- Headache1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE DURING A LEAD REPLACEMENT PROCEDURE (RELATED MANUFACTURER REFERENCE NUMBER: 3006705815-2023-07067 ) ON (B)(6) 2023, THE PATIENT EXPERIENCED A CSF LEAK WHEN THE DOCTOR ATTEMPTED TO PLACE THE EPIDURAL NEEDLE. THE DOCTOR ACCESSED A DIFFERENT LEVEL AND COMPLETED THE IMPLANT. IN RECOVERY, THE PATIENT EXPERIENCED HEADACHE. REPORTEDLY, THE PATIENT WAS INSTRUCTED TO LAY FLAT WHICH RESOLVED THE HEADACHE.
Patient problems: Cerebrospinal Fluid Leakage; Headache
MAUDE report 18539921 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K053318. One submission often covers many models, so check the product and lot details in each record.
- Z-0087-2018 · Jul 24, 2017 · TerminatedRX-2 COUDE Epidural Needle, 16g x 3.5in (8.9cm)TW, 10 units, Calibrated, Plastic Hub, Detachable Wing, Blunt Stylet, Sterile, Rx only, For Use with 19g or Smaller Catheter
Other NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) devices
- ARROW IPN922632Teleflex Incorporated · NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)2 recalls0 reports
- ARROW IPN922603Teleflex Incorporated · NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)1 recall0 reports
- ARROW IPN922605Teleflex Incorporated · NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)1 recall0 reports
- 22G 1 1/2IN Regional Block Needle 408348Becton, Dickinson And Company · NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)1 recall0 reports
- ARROW IPN923597Teleflex Incorporated · NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)1 recall0 reports
- ARROW IPN922631Teleflex Incorporated · NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)1 recall0 reports
- ARROW IPN922604Teleflex Incorporated · NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)1 recall0 reports
- BD QUINCKE Spinal Needles 405180Becton, Dickinson And Company · NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)23 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.