OptiSeal™ 1000093-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00821329600579), received between Sep 21, 2016 and Aug 20, 2022 — classified as 1 injury, 20 malfunctions.

The most frequently reported specific device problem is “Material Separation” (17 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, 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 ↗
• 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 ↗
• 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 4, 2018Material Separation; Use of Device Problem; Material Split, Cut or Torn; Material Separation; Use of Device Problem; Material Split, Cut or Torn

  AS REPORTED THE SHEATH SPLIT INTO 3 PIECES AND REQUIRED THAT THE DISTAL END TO BE REMOVED WITH A HEMP STAT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7936092 ↗
• MalfunctionFeb 7, 2018Material Separation; Material Separation

  AS REPORTED AS THE SHEATH IS SPLIT, ONE SIDE COMPLETELY BREAKS OFF OF THE SHEATH. HEMOSTATS WERE REQUIRED TO REMOVE FROM THE BODY. NO REPORTED ADVERSE PATIENT EVENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7247536 ↗
• MalfunctionJan 31, 2018Material Separation; Material Separation

  AS REPORTED: WHEN MD WENT TO BREAK OR TEAR THE SHEATH, THE EARS SNAPPED OFF SO HAD NO WAY TO SPLIT IT. NO ADVERSE PATIENT EFFECTS. SHEATH WAS EVENTUALLY PEELED AWAY PIECE BY PIECE USING OTHER TOOLS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7232172 ↗
• MalfunctionJan 31, 2018Material Separation; Material Separation

  AS REPORTED THE WING OF SPLITTABLE OPTISEAL SHEATH BROKE WHEN TRYING TO SPLIT THE SHEATH FOR REMOVAL. A HEMOSTAT HAD TO BE USED TO GRIP THE REMAINING PLASTIC HUB OF THE SHEATH TO COMPLETE THE SPLITTING PROCESS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7230727 ↗
• MalfunctionOct 16, 2017Material Separation; Material Separation

  IT WAS REPORTED THAT THE HUB OF THE INTRODUCER DID NOT CRACK AND SPLIT PROPERLY. SEVERAL ATTEMPTS TO SPLIT HUB WITH CLAMPS WERE UNSUCCESSFUL. A BLADE WAS USED TO CUT THE HUB.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6951127 ↗
• MalfunctionOct 11, 2017Material Separation; Material Separation

  AS REPORTED DURING SPLITTING/PEELING OF THE SHEATH, THE LEFT HANDLE OF THE SHEATH BROKE OFF (SEPARATE FROM THE SHEATH ARM) SO THE PHYSICIAN ATTEMPTED TO GRIP THAT PORTION OF THE SHEATH (NEXT TO THE VALVE AREA) WITH HEMOSTAT BUT DURING THIS INADVERTENTLY DAMAGED THE RA LEAD INSULATION. THE PHYSICIAN THEN MADE THE DECISION TO REPLACE THE LEAD. THE HELIX WAS RETRACTED AND THE LEAD WAS REMOVED AND A NEW SHEATH AND LEAD WERE INSERTED OVER A PREVIOUSLY RETAINED GUIDEWIRE TO INSERT THE NEW RA LEAD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6941896 ↗
• MalfunctionAug 9, 2017Material Separation; Material Separation

  AS REPORTED WHEN THE PHYSICIAN PULLS AWAY THE SHEATH USING THE TAB IT BREAKS OFF. THERE WERE NO PATIENT EFFECTS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6777119 ↗
• MalfunctionJul 21, 2017Material Separation; Material Separation

  AS REPORTED: WHEN THE PHYSICIAN WAS BREAKING AWAY THE SHEATH - BOTH TABS BROKE OFF, AND THE HUB BROKE INTO SEVERAL PIECES. THE PHYSICIAN HAD TO USE SOME CLAMPS TO TEAR IT AWAY. NO ISSUE FOR PATIENT. THIS EVENT IS RELATED TO MDR 2183787-2017-00087.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6731741 ↗
• MalfunctionJul 21, 2017Material Separation; Material Separation

  AS REPORTED: WHEN THE PHYSICIAN WAS BREAKING AWAY THE SHEATH - BOTH TABS BROKE OFF, AND THE HUB BROKE INTO SEVERAL PIECES. THE PHYSICIAN HAD TO USE SOME CLAMPS TO TEAR IT AWAY. NO ISSUE FOR PATIENT. THIS EVENT IS RELATED TO MDR 2183787-2017-00086.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6731737 ↗
• MalfunctionJul 20, 2017Material Separation; Material Separation

  AS REPORTED DR. (B)(6) HAD THE WING SNAP OFF OF THE SHEATH PRIOR TO PEELING THE SHEATH AWAY. THIS EVENT IS RELATED TO MDR 2183787-2017-00080.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6730217 ↗
• MalfunctionJul 14, 2017Material Separation; Material Separation

  AS REPORTED DR. (B)(6) HAD THE WING SNAP OFF OF THE SHEATH PRIOR TO PEELING THE SHEATH AWAY. THIS EVENT IS RELATED TO MDR 2183787-2017-00084.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6714993 ↗
• MalfunctionDec 5, 2016Material Separation; Material Separation

  AS REPORTED THE ARM OF THE PEEL AWAY SHEATH BROKE OFF AND THE SHEATH NEEDED TO BE CUT. THE SHEATH WAS BEING CUT CHUNKS OF THE SHEATH WERE FALLING OFF INTO THE WOUND. SHEATH WAS REMOVED FROM PATIENT'S CHEST SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6144534 ↗
• MalfunctionNov 28, 2016Material Separation; Material Separation

  IT WAS REPORTED THAT THE HUB BROKE INTO 3 PIECES INTO THE INCISION SITE. THE PHYSICIAN PICKED OUT PIECES AND CLOSED THE INCISION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6129168 ↗
• MalfunctionOct 13, 2016Material Separation; Material Separation

  IT WAS REPORTED THAT THE WING OF THE PEELABLE INTRODUCER BROKE DURING THE PEEL PHASE. SMALL SCISSORS WERE USED TO SPLIT THE INTRODUCER. THERE WAS CONCERN THAT PARTICULATES FROM THE SPLIT INTRODUCER COULD GET INTO THE INCISION SITE. AS A RESULT, THE SHEATH AND LEAD NEEDED TO BE REMOVED. THE PROCEDURE RESTARTED WITH A NEW INCISION SITE IN THE VENA SUBCLAVIA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6025463 ↗
• MalfunctionSep 21, 2016Material Separation; Material Separation

  IT WAS REPORTED THAT WHEN TRYING TO SPLIT THE SHEATH THE LEFT-HAND WING BROKE OFF AT THE JUNCTURE WITH THE VALVE. A KELLY CLAMP WAS USED TO SPLIT THE SHEATH. THERE WERE TINY RESIDUAL PIECES OF PLASTIC THAT LANDED ON THE INCISION SITE. THE PIECES WERE REMOVED AND THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5967014 ↗