SURGICEL 1951SRecalls & reported problems
Ethicon Sàrl · Absorbable Hemostat (oxidized regenerated cellulose) · Class 3 · Implant
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705031468108), received between Nov 21, 2023 and Apr 22, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Device Markings/Labelling Problem” (1 report).
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
- Device Markings/Labelling Problem1
Patient problems
- Abscess1
- Headache1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- Swelling/ Edema1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 22, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE HEMOSTAT WAS USED. THERE WERE TWO PRODUCTS, BOTH ABSORBABLE HEMOSTAT THAT SEEM TO HAVE BEEN MISLABELED AND WANTED TO BRING UP TO THE MANUFACTURER'S ATTENTION TO SEE IF IT'S A NEW OR OLDER ISSUE. THE PRODUCT IS LABELED FOR 2 IN X 14 IN, HOWEVER, THE PRODUCT SEEMS TO BE 2 IN X 4 INCH. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21882869 ↗InjuryNov 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A NEUROSURGERY PROCEDURE FOR AVM: ARTERIOVENOUS MALFORMATION ON AN UNKNOWN DATE AND AN ABSORBABLE HEMOSTAT WAS USED. AN MRI WAS PERFORMED 10 DAYS LATER AND REVEALED A SUBDURAL AND EPIDURAL EFFUSION AND WORSENING CEREBRAL EDEMA THAT WAS NOT PRESENT THE DAY AFTER SURGERY. DWI DID NOT SHOW HIGH SIGNAL, AND IT SEEMS DIFFICULT TO SAY THAT IT IS AN ABSCESS AT PRESENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Abscess; Headache; Insufficient Information; Swelling/ Edema
MAUDE report 18187472 ↗
Other Agent, absorbable hemostatic, non-collagen based devices
- ETHICON 3013SPEthicon, LLC · Agent, absorbable hemostatic, non-collagen based3 deaths392 reports
- SURGICEL FIBRILLAR 1961Ethicon Sàrl · Agent, absorbable hemostatic, non-collagen based1 recall2 deaths120 reports
- SURGICEL FIBRILLAR 1963Ethicon Sàrl · Agent, absorbable hemostatic, non-collagen based1 recall44 reports
- SURGICEL 1953Ethicon Sàrl · Agent, absorbable hemostatic, non-collagen based56 reports
- SURGICEL 1952Ethicon Sàrl · Agent, absorbable hemostatic, non-collagen based1 death41 reports
- SURGICEL FIBRILLAR 1962Ethicon Sàrl · Agent, absorbable hemostatic, non-collagen based35 reports
- Veriset HP0510ECovidien LP · Agent, Absorbable Hemostatic, Non-Collagen Based1 death33 reports
- SURGICEL SNoW 2082Ethicon, LLC · Agent, absorbable hemostatic, non-collagen based24 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.