Destino Twist Steerable Guiding SheathRecalls & reported problems across all models
Oscor Inc. · 19 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 45
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls
- 1
We found 19 models of Destino Twist Steerable Guiding Sheath by Oscor Inc. in the FDA's device registry (GUDID). Together they are named in 45 adverse event reports in the FDA's MAUDE database, received between Jan 9, 2017 and Aug 18, 2026 — classified as 6 injuries, 39 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (12 reports).
1 FDA recall record name at least one of these models by its device identifier.
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
Reports received per month, all models
Destino Twist Steerable Guiding Sheath recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Dec 22, 2021Completed
There is potential for separation between the threaded hub and threaded cap at the proximal end of the device.
Z-0646-2022 · Root cause: Process control · Recall details · FDA record ↗
Most reported Destino Twist Steerable Guiding Sheath problems
Device problems
- Fluid/Blood Leak12
- Break7
- Deformation Due to Compressive Stress5
- Detachment of Device or Device Component4
- Material Fragmentation3
- Mechanical Jam3
- Defective Device2
- Difficult to Advance2
Patient problems
- No Clinical Signs, Symptoms or Conditions26
- No Known Impact Or Consequence To Patient9
- No Consequences Or Impact To Patient4
- Air Embolism1
- Aneurysm1
- Arteriosclerosis/ Atherosclerosis1
- Atrial Fibrillation1
- Blood Loss1
Destino Twist Steerable Guiding Sheath models
19 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Destino Twist Steerable Guiding Sheath DST1405525INTRODUCER, CATHETER1 recall0 reports
- Destino Twist Steerable Guiding Sheath DST0655509INTRODUCER, CATHETER6 reports
- Destino Twist Steerable Guiding Sheath DCT1357125NMINTRODUCER, CATHETER6 reports
- Destino Twist Steerable Guiding Sheath DST0704509INTRODUCER, CATHETER5 reports
- Destino Twist Steerable Guiding Sheath DST0705509INTRODUCER, CATHETER5 reports
- Destino Twist Steerable Guiding Sheath DST0654509INTRODUCER, CATHETER4 reports
- Destino Twist Steerable Guiding Sheath DST0654509TDINTRODUCER, CATHETER2 reports
- Destino Twist Steerable Guiding Sheath DST0705517INTRODUCER, CATHETER2 reports
- Destino Twist Steerable Guiding Sheath DST0855517INTRODUCER, CATHETER2 reports
- Destino Twist Steerable Guiding Sheath DST0856517INTRODUCER, CATHETER2 reports
- Destino Twist Steerable Guiding Sheath DST1209030INTRODUCER, CATHETER2 reports
- Destino Twist Steerable Guiding Sheath DST1207122INTRODUCER, CATHETER2 reports
- Destino Twist Steerable Guiding Sheath DST0655509TDINTRODUCER, CATHETER1 report
- Destino Twist Steerable Guiding Sheath DST0655517INTRODUCER, CATHETER1 report
- Destino Twist Steerable Guiding Sheath DST0706509INTRODUCER, CATHETER1 report
- Destino Twist Steerable Guiding Sheath DST0706509TDINTRODUCER, CATHETER1 report
- Destino Twist Steerable Guiding Sheath DST1387139INTRODUCER, CATHETER1 report
- Destino Twist Steerable Guiding Sheath DST0655507D2INTRODUCER, CATHETER1 report
- Destino Twist Steerable Guiding Sheath DST1207522INTRODUCER, CATHETER1 report
Recent Destino Twist Steerable Guiding Sheath adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 18, 2026Fluid/Blood Leak
Patient problems: Fibrosis; Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions
MAUDE report 50302999 ↗MalfunctionAug 17, 2026Deformation Due to Compressive Stress
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50279507 ↗MalfunctionJun 12, 2025Fluid/Blood Leak; Fluid/Blood Leak
DURING THE PROCEDURE, THE STROKE (GREEN) ON THE SIDE WAS LEAKING. THE GREEN HUB FROM THE HEMOSTASIS VALVE WAS LEAKING ON THE SIDE. THE PATIENT IS WELL. THE INTERVENTION WAS DONE WITH ANOTHER DESTINO TWIST. THE PROCEDURE WAS AN ENDOLEAK EMBOLIZATION WHICH WAS THE INTERVENTION. THE PATIENT WAS NOT AT RISK. HE IS DOING WELL AND NO FURTHER INTERVENTION WAS NECESSARY. THE TIME DELAY FOR THIS PROBLEM WAS APPROX. 15 - 20 MINUTES. THE CASE WAS REPORTED TO THE SWISS AUTHORITY SWISSMEDICS. DEVICE WILL BE RETURNED TO OSCOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22193654 ↗MalfunctionSep 6, 2024Fluid/Blood Leak; Fluid/Blood Leak
DURING A BRANCHED ENDOVASCULAR AORTIC REPAIR (EVAR) PROCEDURE, AFTER INSERTING THE STEERABLE SHEATH INTO THE BODY OF THE PATIENT, ACCORDING TO THE DOCTOR, THERE SEEMED TO BE A LEAK BETWEEN THE SIDEPORT AND THE HANDLE OF THE STEERABLE SHEATH. AS A RESULT, THE BLOOD WAS RUNNING OUT OF THE SIDE OF THE HANDLE RETROGRADE. AN UNKNOWN MODEL AND LOT NUMBER OF A TERUMO GUIDEWIRE WAS USED IN CONJUNCTION WITH THE OSCOR STEERABLE SHEATH IN THIS PROCEDURE. THE PATIENT IS STABLE; THERE WAS NO ADVERSE IMPACT TO THE PATIENT OR THE USER. NO ADDITIONAL SURGICAL INTERVENTION NOR ANY EXTENDED HOSPITALIZATION WAS REQUIRED, HOWEVER THERE WAS AN APPROXIMATE 10-MINUTE DELAY. ANOTHER OSCOR STEERABLE SHEATH MODEL DST0705517 WAS USED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT IDENTIFICATION INFORMATION IS AVAILABLE. IT IS UNKNOWN IF THE PATIENT LOSS ANY BLOOD, OR IF THEY REQUIRED A BLOOD TRANSFUSION, AS THIS INFORMATION WAS NOT PROVIDED BY THE DOCTOR. THIS DESTINO TWIST WILL BE RETURNED FOR EVALUATION, HOWEVER, THE TERUMO GUIDEWIRE USED IN THIS PROCEDURE WILL NOT BE RETURNED FOR EVALUATION WITH THIS DESTINO TWIST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20161627 ↗InjurySep 4, 2024Mechanical Jam; No Apparent Adverse Event; Mechanical Jam; No Apparent Adverse Event
DURING THE PROCEDURE ENDO LEAK POSITION SEARCH AND RENAL STENT PROLONGATION, THE PHYSICIAN HAD TO USE AN 8.5F DESTINO TWIST. HE INSERTED THE SHEATH AND ONCE ON THE CORRECT POSITION, WANTED TO BEND THE CURVE OF THE DESTINO. AS SOON AS HE DID THIS, THE DEVICE SCRATCHED AND WAS NOT USABLE ANYMORE (MEANING THE CURVE HAS NOT BEEN POSSIBLE TO DO). THE PHYSICIAN DECIDED THEN TO TAKE ANOTHER DEVICE IN 8.5F BUT THE SAME PROBLEM HAPPENED. NO HARM TO THE PATIENT. TWO DEVICES WERE USED FOR THAT PROCEDURE TO BE DONE, INSTEAD OF THAT, NO ADVERSE EVENT. DEVICE TO BE RETURNED TO OSCOR. 07/12/2024: CUSTOMER REPORTED A DELAY IN THE PROCEDURE, ANOTHER SHEATH HAS BEEN TAKEN WHICH BROKE AS WELL. THE PHYSICIAN WENT NERVOUS, AND THEY HAD TO FIGURE OUT ANOTHER SOLUTION TO DO THE PROCEDURE. THE PHYSICIAN ACCESSED THE FEMORAL ARTERY WITH FIRST A SHORT 7F SHEATH AND THEN DIRECTLY THROUGH THE SKIN WENT WITH THE DESTINO. SECOND LOT NUMBER REPORTED FOR DP-21586 WILL BE PROCESSED UNDER (B)(4). SUBMITTED FOR ADMINISTRATIVE PURPOSES: 07/29/2024: RECEIVED CONFIRMATION THAT A DELAY OF MORE THAN 30 MINUTES IN TOTAL IS CONFIRMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20134405 ↗MalfunctionMar 5, 2024Break; Break
THE CUSTOMER REPORTED THAT WHEN THE SCRUB NURSE RECEIVED THE DESTINO TWIST SHEATH ON HER TABLE, THE LATERAL CANNULA FELL DOWN FROM THE HANDLE OF THE SHEATH. IT SEEMS THE CANNULA WAS NOT CONNECTED TO THE HANDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18837831 ↗MalfunctionFeb 10, 2024Fluid/Blood Leak; Fluid/Blood Leak
ACCORDING TO THE CORRECT APPLICATION, THE HEMOSTASIS VALVE IS LEAKING AT THE SIDE OF THE HOUSING. THE PATIENT IS FINE. THERE WAS NO DANGER TO THE PATIENT AT ANY TIME. THERE WAS ONLY A DELAY IN THE OPERATION OF APPROX. 10 MINUTES DUE TO THE EXCHANGE FOR A CORRECT DESTINO TWIST. THE REPLACEMENT PRODUCT WAS THE IDENTICAL DESTINO TWIST SHEATH. THE OPERATION WAS PERFORMED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18682652 ↗InjuryOct 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED THAT DURING A FENESTRATED ENDOVASCULAR AORTIC REPAIR PROCEDURE AT THE FIRST ANGULATION OF THE SHEATH AT THE LEVEL OF THE TRUNCUS COELIACUS, THE PHYSICIAN STATED THAT THE SHEATH KINKED, AND IT WAS NO LONGER POSSIBLE FOR HIM TO PASS WITH THE WIRE. HE FINISHED THE PROCEDURE SUCCESSFULLY WITH INCREASED EFFORT WITHOUT A STEERABLE SHEATH. THE CUSTOMER REPORTED APPROX. 30-MINUTE DELAY IN THE PROCEDURE. SUBMITTED FOR ADMINISTRATIVE PURPOSES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17908272 ↗MalfunctionSep 29, 2023Difficult to Advance; Difficult to Advance
STAFF ADVISED THESE 2 DEVICES WERE ATTEMPTING TO BE USED AND FOUND THE INTERNAL LUMEN UNPASSABLE WITH DILATOR OR WIRE AFTER TORQUING DEVICE IN ILIAC ARTERY. BOTH DEVICES HAD TO BE CUT IN ORDER TO RETRIEVE THEM. ANOTHER 7.5FR DEVICE WAS ACCESSED WHICH WAS ABLE TO BE USED TO COMPLETE THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17848136 ↗MalfunctionSep 8, 2023Difficult to Advance; Difficult to Advance
ADDITIONAL INFORMATION RECEIVED STATES THE PROCEDURE PERFORMED WAS AN INTERNAL ILIAC REINTERVENTION. THE ONLY DEVICE INSERTED THROUGH THE SHEATH WAS THE WIRES, BUT NOT AT THE TIME OF "CURVING". THE STEERABLE SHEATHS WERE CUT TO RETRIEVE THEM. PROCEDURE DELAY IS UNKNOWN AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17710559 ↗MalfunctionDec 6, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
IT WAS REPORTED THE DESTINO TWIST WAS BENT PROXIMAL TO THE CURVE AND THE DOCTORS COULD NOT GET THE DEVICES THROUGH THE INTRODUCER (SHEATH); IN THE BEGINNING OF THE PROCEDURE THE DOCTORS HAD NOT NOTICED THE DESTINO TWIST WAS BENT. THEY DECIDED TO SWITCH TO AN APTUS 7F, THIS WORKED, BUT NOT FOR ALL REQUIREMENTS. THEY THEN TRIED USING THE DESTINO TWIST AGAIN, BUT AGAIN, THEY WERE NOT ABLE TO GET THE DEVICES THROUGH THE LUMEN (SHEATH) DUE TO THE KINK BEFORE THE CURVE. THEY DECIDED TO USE A NEW DESTINO TWIST (SAME MODEL AND LOT NUMBER) AND IT WORKED. IT WAS REPORTED THERE WAS MORE THAN A 30 MINUTE DELAY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15925579 ↗MalfunctionNov 17, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A RENAL STENTING PROCEDURE THE DESTINO TWIST DEFLECTABLE STEERABLE GUIDING SHEATH VALVE CAME OFF OF BACK. THERE WAS NO HARM TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT THE DESTINO TWIST DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15818991 ↗MalfunctionJul 11, 2022Fluid/Blood Leak; Mechanical Jam; Fluid/Blood Leak; Mechanical Jam
IT WAS REPORTED THAT THE THREE UNITS ALL SHOWED THE SAME PROBLEMS. DURING A FEVAR CASE IT WAS NOTICED AT START THEY WERE NOT ABLE TO CLICK THE PUSHER INTO THE HANDLE, IN ALL THREE AFFECTED UNITS. WHEN CANNULATING A SIDEBRANCH AND TURNING THE ROTATING WHEEL TO ADJUST THE CURVE A "POP" WAS FELT IN THE HANDLE. THE ROTATING WHEEL WAS STILL FUNCTIONING BUT THE CONNECTION BETWEEN HANDLE AND CATHETER WAS NOT FUNCTIONING, FELT SEPARATED. WHEN TURNING THE HANDLE ITSELF TO ROTATE THE TIP LEFT/RIGHT THERE WAS NO ROTATION OF THE TIP, NEXT TO THIS THE HANDLE STARTING LEAKING AND WHEN INTRODUCING A BERENSTEIN CATHETER THEY WERE NOT ABLE TO ADVANCE. AFTER CANNULATING THE FIRST, SECOND AND THIRD BRANCH THEY EVERY TIME HAD TO OPEN AND USE A NEW UNIT. ADDITIONAL DEVICE USED IN COMBINATION WITH THE OSCOR PRODUCT DURING THE PROCEDURE COOK FEVAR CUSTOM MADE GRAFT, ACCESS SHEATH GORE DRYSEAL 20F. DUE TO EXTRA EXCHANGES OF NEW UNITS AND WORKING WITH THE DEFECTIVE UNITS, DELAY 60 MINUTES. THE FOURTH THAT WAS OPENED WAS A SIMILAR UNIT BUT WITH LOT NUMBER: DP-15026. THIS UNIT WORKED NORMAL IN THE SAME PATIENT. SINCE 2016 THE UMCG HAS USED AROUND 400 UNITS OF DESTINO TWIST. THE MAJORITY OF CASES WITH THE DES
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14982323 ↗MalfunctionJun 15, 2022Mechanical Jam; Output Problem
ONE OF THE SUPPLIES OSCOR TWIST SHEARABLE SHEATH MALFUNCTIONED. THE DILATOR WOULDN'T ADVANCE INTO THE SHEATH, IT WAS STUCK.
Patient problems: Insufficient Information
MAUDE report 14694937 ↗MalfunctionJun 2, 2022Break; Break
IT WAS REPORTED DURING A FENESTRATE AORTIC PROSTHESIS PROCEDURE, BY WAY OF ILIAC ACCESS, THE DESTINO TWIST SHEATH HANDLE DETACHED WHEN IT WAS TURNED (WITHOUT MUCH PRESSURE). THE PHYSICIAN WAS NOT CERTAIN HOW MANY CATHETERS HE HAD ALREADY USED THROUGH THE DESTINO TWIST, HOWEVER, A NEW DESTINO TWIST WAS USED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT IS STABLE. THE PROCEDURE WAS PROLONGED BY 30 MINUTES, AS THE OPERATION WAS VERY COMPLEX. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14575397 ↗
Other Oscor Inc. products
- Introducer Kit for Impella11 models · 1,326 reports · 9 recalls
- Guidestar Steerable Guiding Sheath2 models · 103 reports · 1 recall
- SafeSheath II14 models · 146 reports
- SafeSheath Ultra Lite3 models · 24 reports · 1 recall
- Occlutech Delivery Set III10 models · 39 reports
- TourGuide Steerable Sheath9 models · 37 reports
- DiRex Steerable Sheath7 models · 22 reports
- Lead Adaptor3 models · 20 reports
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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