Destino Twist Steerable Guiding Sheath DST0655509Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00885672004019), received between May 10, 2019 and Aug 18, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K140406); 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. 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 6 most recent of 6 reports, 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 ↗
• 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 ↗
• InjuryAug 31, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED A SMA STENT PROCEDURE WAS TO BE PERFORMED. THEY WERE ABLE TO GAIN ACCESS AND CANNULATED THE SMA ARTERY WITH THE STEERABLE SHEATH AND CONTRAST INJECTION WAS PERFORMED. AFTER MEASURING THE ANATOMY AND GETTING READY TO PLACE THE STENT THEY TRIED TO PERFORM A VERIFICATION CONTRAST INJECTION AND CONTRAST BEGAN TO LEAK FROM WITHIN THE HANDLE. THE PROCEDURE WAS STOPPED. PATIENT WAS TAKEN TO OR FOR ADDITIONAL OPEN SURGERY. PATIENT LOSS 200 CC, HOWEVER, NO BLOOD TRANSFUSION WAS REQUIRED. PATIENT IS ALIVE, EXTENDED HOSPITAL STAY WAS REQUIRED AFTER SURGERY.

  Patient problems: Arteriosclerosis/ Atherosclerosis

  MAUDE report 12395075 ↗
• MalfunctionJun 11, 2019Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING SELECTIVE CATHETERIZATION OF THE LEFT RENAL ARTERY WITH DRUG-ELUTING BALLOON ANGIOPLASTY AND STENTING THE DILATOR IS INCONSISTENT WITH THE SHEATH SIZE. THE OBTURATOR WAS NOT FLEXIBLE ENOUGH TO GO THROUGH THE UNI- DIRECTIONAL CURVE OF THE SHEATH. PATIENT OUTCOME IS FINE. NO MEDICAL INTERVENTION OR ADVERSE EVENT REPORTED. USER USED THE SAME PRODUCT TO COMPLETE THE SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8688178 ↗
• MalfunctionMay 10, 2019Failure to Advance; Device-Device Incompatibility

  PRODUCT MALFUNCTION. THE DIALATOR IS INCONSISTENT WITH THE SHEATH SIZE. THE OBTURATOR WAS NOT FLEXIBLE ENOUGH TO GO THROUGH THE UNI-DIRECTIONAL CURVE OF THE SHEATH. BRIEF HISTORY & INDICATIONS: ADVANCED ATHEROSCLEROSIS WHO UNDERWENT PRIOR LEFT RENAL STENTING WITH A BALLOON EXPANDABLE COVERED STENT. HE HAS RIGHT RENAL ATROPHY AND WAS NOTED TO HAVE HIGH-GRADE STENOSIS OF HIS LEFT RENAL ARTERY JUST DISTAL TO THE STENT LIKELY SECONDARY TO INTIMAL HYPERPLASIA. HE WAS THEREFORE OFFERED BALLOON ANGIOPLASTY AND STENT EXTENSION. PROCEDURAL NOTE: NO MENTION OF EVENT IN PROCEDURAL NOTE BUT PROCEDURAL METHODOLOGY UTILIZED DESCRIBED AS FOLLOWS: ULTRASOUND-GUIDED ACCESS OF THE RIGHT COMMON FEMORAL ARTERY WAS PERFORMED USING A 21-GAUGE MICROPUNCTURE SET. DUE TO SCAR TISSUE THIS WAS DILATED UP TO A 9 FRENCH DILATOR OVER A STIFF AMPLATZ WIRE. A 6.5 FRENCH OSCOR TWIST CONFORMABLE SHEATH WAS THEN ADVANCED UP TO THE LEVEL OF THE LEFT RENAL ARTERY STENT. UNDER FLUOROSCOPIC GUIDANCE THE CONFORMABLE SHEATH WAS USED TO SELECTIVELY CATHETERIZE THE PROXIMAL ASPECT OF THE STENT AND A GLIDEWIRE AND QUICK CROSS CATHETER WERE ABLE TO BE EASILY ADVANCED TO THE RENAL HILUM. THE GLIDEWIRE WAS THEN EXCHANGED FOR A

  Patient problems: Stenosis

  MAUDE report 8599167 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K140406. One submission often covers many models, so check the product and lot details in each record.

• Z-0646-2022 · Dec 22, 2021 · Completed
  Destino Twist 14F (also branded as Guidestar 14F)