OptiSealRecalls & reported problems across all models
Greatbatch Ltd · 8 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 36
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 0
We found 8 models of OptiSeal by Greatbatch Ltd in the FDA's device registry (GUDID). Together they are named in 36 adverse event reports in the FDA's MAUDE database, received between Jan 29, 2016 and Aug 20, 2022 — classified as 2 injuries, 34 malfunctions.
The most frequently reported specific device problem is “Material Separation” (21 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Most reported OptiSeal problems
Device problems
- Material Separation21
- Leak/Splash5
- Material Integrity Problem5
- Fracture4
- Adverse Event Without Identified Device or Use Problem3
- Break2
- Fluid/Blood Leak1
- Loss of or Failure to Bond1
Patient problems
- No Consequences Or Impact To Patient18
- No Known Impact Or Consequence To Patient10
- No Clinical Signs, Symptoms or Conditions6
- Blood Loss1
- Exposure to Body Fluids1
- Laceration(s)1
- Perforation of Vessels1
OptiSeal models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- OptiSeal™ 1000093-001Introducer, Catheter21 reports
- OptiSeal™ 1000093-004Introducer, Catheter8 reports
- OptiSeal™ 1000093-002Introducer, Catheter2 reports
- OptiSeal™ 1000093-015Introducer, Catheter1 report
- OptiSeal™ 1000093-009Introducer, Catheter1 report
- OptiSeal™ 1000093-006Introducer, Catheter1 report
- OptiSeal™ 1000093-008Introducer, Catheter1 report
- OptiSeal™ 1003975-004Introducer, Catheter1 report
Recent OptiSeal adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 20, 2022Fracture; Material Integrity Problem; Fracture; Material Integrity Problem
OPTISEAL PEEL INTRODUCER "WING" BROKE OFF WHEN ATTEMPTING TO SPLIT THE SHEATH. AT THIS TIME, THE DISTRIBUTOR IS UNABLE TO PROVIDE FURTHER FOLLOW-UP INFORMATION REGARDING PARTICULATES BEING GENERATED AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15262984 ↗MalfunctionAug 10, 2022Break; Fracture; Break; Fracture
THE WING ON THE OPTISEAL 6F SHEATH BROKE AWAY FROM THE SHEATH AS THE PHYSICIAN ATTEMPTED TO BREAK THE SHEATH. I HAVE PICTURES I CAN SEND AS WELL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15205494 ↗InjuryMay 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
GOOD MORNING, I HAD A SIGNIFICANT ISSUE WITH AN OPTISEAL 6F SHEATH THIS MORNING DURING A PACEMAKER IMPLANT. THE IMPLANTING PHYSICIAN WAS INJURED/CUT DURING USAGE OF THE SHEATH. I AM NOT SURE WHAT TO DO FROM HERE. WOULD SOMEONE PLEASE GIVE ME A CALL TO DISCUSS FURTHER.
Patient problems: Exposure to Body Fluids; Laceration(s)
MAUDE report 14437727 ↗MalfunctionApr 21, 2022Fracture; Material Integrity Problem; Fracture; Material Integrity Problem
DURING A ROUTINE PACEMAKER IMPLANT THE PHYSICIAN WAS USING AN ABBOTT APPROVED AND ABBOTT SUPPLIED INTRODUCER SHEATH THAT FAILED IT WAS MADE BY GREATBATCH MEDICAL. THE SHEATHS TAB HANDLE SHEARED OFF OF THE SIDE OF THE HUB WHILE THE PHYSICIAN WAS TRYING TO PEEL IT AWAY FROM THE LEAD. HE THEN NEEDED TO CRUDELY GRASP THE SIDE OF THE HUB WITH A HEMOSTAT CLAMP TO DETACH THE LEAD THUS RISKING THE INSULATION AND THE LEAD ITSELF. THESE SHEATHS WERE NEWLY APPROVED AS THE EXCLUSIVE INTRODUCER SHEATH TO BE USED BY THE CRM DIVISION. WE CAN NO LONGER ORDER THE MERIT MEDICAL BRAND THAT WE'VE USED SUCCESSFULLY FOR YEARS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14167583 ↗MalfunctionDec 21, 2021Loss of or Failure to Bond; Material Integrity Problem; Loss of or Failure to Bond; Material Integrity Problem
IT WAS REPORTED THAT: PER ON INTRODUCER HUB AND WINGS BROKE OFF. LOT # W6455325. NO PATIENT HARM OR EFFECTS ON PROCEDURE. (B)(6) CALLER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13057474 ↗MalfunctionJun 25, 2021Break; Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem
AS REPORTED: BOTH "WINGS" OF INTRODUCER BROKE OFF WHEN TRYING TO SPILT THE SHEATH. MAIN BODY OF SHEATH HAD TO BE CUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12064828 ↗MalfunctionApr 5, 2021Material Frayed; Material Integrity Problem; Material Frayed; Material Integrity Problem
WHEN SHEATH WAS SPLIT, IT FRAYED SO THAT A SLIVER OF THE INTRODUCER WAS SHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11617040 ↗MalfunctionMay 21, 2019Material Separation; Material Separation
DR. (B)(6) ATTEMPTED TO SPLIT THE 6 FR SHEATH THE WING BROKE OFF. PHYSICIAN HAD TO USE AN INSTRUMENT TO HOLD AND BREAK SHEATH. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8630166 ↗MalfunctionJan 15, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT WHEN THEY TOOK THE DILATOR OUT OF THE SHEATH, THE VALVE LEAKED BLOOD THROUGH IT. THE VALVE WAS NOT PREVENTING BLEEDBACK, BUT RATHER JUST ALLOWING BLOOD TO COME THROUGH THE VALVE. THE PHYSICIAN SAID HE HAD TO HURRY AND PUT THE LEAD DOWN QUICKER SINCE IT WAS LEAKING. THERE WAS NO REPORTED IMPACT ON THE PATIENT. THE WAS JUST A NUISANCE FOR THE PHYSICIAN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8248877 ↗MalfunctionDec 4, 2018Leak/Splash; Leak/Splash
AS REPORTED: BLOOD EGRESS WHEN DILATOR REMOVED AFTER INSERTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8129363 ↗MalfunctionNov 28, 2018Leak/Splash; Leak/Splash
AS REPORTED THIS SHEATH DID NOT HAVE HOMEOSTASIS. A VERY SLOW/SMALL AMOUNT OF BLOOD EGRESSED. THE BLOOD SLOWLY FILLED THE CUP AREA AN THEN DRIP. THIS HAPPENED AFTER DILATOR WAS REMOVED PRIOR TO LEAD INSERTION. THE INTRODUCER WAS USED AND WHEN LEAD WAS INSERTED THERE WAS HEMOSTASIS. THIS IS A SIMILAR EVENT AS MDR 2183787-2018-00078, MDR 2183787-2018-00079, AND MDR 2183787-2018-00080.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8112011 ↗MalfunctionNov 15, 2018Leak/Splash; Leak/Splash
IT WAS REPORTED THAT INTRA-OPERATIVELY, THE INTRODUCER VALVE HAD BLOOD SLOWLY EGRESSING. THE INTRODUCER REMAINED IN USE FOR THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8073923 ↗MalfunctionOct 25, 2018Material Separation; Material Separation
AS REPORTED SUMMARY THE WING BROKE WHILE ATTEMPTING TO PEEL THE INTRODUCER. PHYSICIAN REMOVED THE LEAD AND REPLACED THE INTRODUCER.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 8006652 ↗MalfunctionOct 19, 2018Leak/Splash; Leak/Splash
THE HEMOSTASIS VALVE LEAKED BLOOD. THE VALVE DID NOT MAINTAIN HEMOSTASIS WITHOUT A LEAD INSERTED. THIS IS A SIMILAR EVENT AS MDR 2183787-2018-00079 AND MDR 2183787-2018-00080.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7985313 ↗MalfunctionOct 17, 2018Leak/Splash; Leak/Splash
IT WAS REPORTED THAT DURING USE, THE HEMOSTASIS VALVE LEAKED BLOOD, AND WOULD NOT MAINTAIN HEMOSTASIS WITHOUT A LEAD INSERTED. THE VALVE WAS NOT USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7973457 ↗
Other Greatbatch Ltd products
All Greatbatch Ltd devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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