Occlutech Delivery Set IIIRecalls & reported problems across all models

We found 10 models of Occlutech Delivery Set III by Oscor Inc. in the FDA's device registry (GUDID). Together they are named in 39 adverse event reports in the FDA's MAUDE database, received between Dec 14, 2022 and Sep 21, 2026 — classified as 6 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (19 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 Occlutech Delivery Set III problems

Occlutech Delivery Set III models

10 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Occlutech Delivery Set III 98DS009

  INTRODUCER, CATHETER
  18 reports
• Occlutech Delivery Set III 98DS012

  INTRODUCER, CATHETER
  5 reports
• Occlutech Delivery Set III 98DS008

  INTRODUCER, CATHETER
  3 reports
• Occlutech Delivery Set III 98DS010

  INTRODUCER, CATHETER
  3 reports
• Occlutech Delivery Set III 98DS011

  INTRODUCER, CATHETER
  3 reports
• Occlutech Delivery Set III 98DS014

  INTRODUCER, CATHETER
  3 reports
• Occlutech Delivery Set III 98DS006

  INTRODUCER, CATHETER
  1 report
• Occlutech Delivery Set III 98US006

  INTRODUCER, CATHETER
  1 report
• Occlutech Delivery Set III 98DL010

  INTRODUCER, CATHETER
  1 report
• Occlutech Delivery Set III 98US011

  INTRODUCER, CATHETER
  1 report

Recent Occlutech Delivery Set III adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Difficult to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50843910 ↗
• MalfunctionJul 28, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50057436 ↗
• InjuryApr 20, 2026Fluid/Blood Leak; Air/Gas in Device

  REASON: AIR EMBOLUS IN DELIVERY SYSTEM NOTICED DURING IMPLANTATION OF PFO (OCCLUTECH IMPLANT) USING ODS III. POSSIBLE INCIDENCE OF VENTRICULAR ARRHYTHMIAS NOTED. PLEASE BE INFORMED OF THE NEW ODSIII COMPLAINT. CUSTOMER COMPLAINT WILL FOLLOW SOON. I WILL BE GLAD TO FORWARD YOUR ADDITIONAL QUESTIONS TO THE CUSTOMER. NOTIFICATION TO OCCLUTECH: 2ND APRIL, LOCATION: (B)(6), DATE: TO BE INVESTIGATED, PRODUCTS: ODS III AND PFO (PRODUCT CODES AND SERIAL NUMBERS BEING INVESTIGATED), DEVICES: PFO IMPLANTED AS PLANNED, NO FURTHER COMPLICATIONS. ODS III NOT RETRIEVED. "[?]" PATIENT: NO COMPLICATIONS REPORTED, ACTION: LOCAL AGENT WILL OBTAIN MORE CLINICAL INFORMATION.

  Patient problems: Air Embolism; Arrhythmia; Tachycardia

  MAUDE report 24931600 ↗
• InjuryFeb 11, 2026Adverse Event Without Identified Device or Use Problem

  PLEASE BE INFORMED OF THE NEW ODSIII COMPLAINTS, DETAILS BELOW. EVENT DESCRIPTION: TRANSIENT ST ELEVATION WITH BRADYCARDIA CONSISTENT WITH AIR EMBOLISM COMPLAINED PRODUCT: 98DS011; DP-18374 (NO DEVICE RETURN). PLEASE NOTE THAT THERE WAS NO DIRECT COMPLAINT RELATED TO THE ODSIII PRODUCT; HOWEVER, DUE TO THE OCCURRENCE OF AIR EMBOLISM, THE EVENT'S RELATIONSHIP TO THE PRODUCT/PROCEDURE WAS ASSESSED AS POSSIBLE. THERE WAS A CAUSAL RELATIONSHIP FOR THIS EVENT (ST ELEVATION DURING THE PROCEDURE). ADDITIONAL MEDICATION / TREATMENT GIVEN BECAUSE OF THE OCCURRENCE OF THIS ADVERSE EVENT. PROCEDURAL TIME WAS 171 MIN. TWO ATTEMPTS WERE PERFORMED FOR DEPLOYING OF MEDICAL ACCESSORY. THERE WERE NO SIGNS OF THROMBOSIS. COUNTRY OF EVENT - GERMANY, PATIENT STATUS / OUTCOME - RESOLVED (MIGHT NEED AN UPDATE) & PROCEDURE BEING PERFORMED AT THE TIME THE ISSUE WAS IDENTIFIED AS AN ATRIAL SEPTAL DEFECT (ASD) CLOSURE.

  Patient problems: Air Embolism

  MAUDE report 24314832 ↗
• InjuryDec 18, 2025Break; Air/Gas in Device; Break; Air/Gas in Device

  DURING THE ATRIAL SEPTAL DEFECT (ASD) CLOSURE PROCEDURE, THE ASD SIZE WAS MEASURED BY TEE, AND AN ASD OCCLUDER DEVICE SIZE 24 MM AND OCCLUTECH DELIVERY SET III 11F WERE SELECTED. THE EQUIPMENT PREPARED BY THE NURSE WHILE FLUSH SHOWED NO ABNORMALITIES. HOWEVER, WHILE THE PHYSICIAN WAS ABOUT TO DEPLOY THE ASD OCCLUDER DEVICE, THE LOADER DEVICE BROKE INTO TWO SEPARATE PARTS. THIS RESULTED IN AIR ENTERING THROUGH THE FRACTURED PROXIMAL END OF THE LOADER DEVICE INTO THE PATIENT'S CIRCULATION, CAUSING BRADYCARDIA. IMMEDIATELY AFTER THE INCIDENT, THE PHYSICIAN ORDERED A RAPID INFUSION OF 200 ML NSS TO CORRECT THE PATIENT'S ARRHYTHMIA AND PROMPTLY REPLACED BOTH THE DELIVERY SET AND THE LOADER DEVICE. THE PROCEDURE WAS DELAYED FOR APPROXIMATELY 10-15 MINUTES, INCLUDING THE TIME REQUIRED TO OPEN A NEW DEVICE AND TO LOAD NSS TO MANAGE THE BRADYCARDIA. THE PROCEDURE WAS THEN CONTINUED AND SUCCESSFULLY COMPLETED. THE PATIENT IS CURRENTLY IN GOOD CONDITION AND HAS NO ONGOING ISSUES. THE DEVICE WILL BE RETURNED.

  Patient problems: Air Embolism; Arrhythmia; Bradycardia

  MAUDE report 23846455 ↗
• MalfunctionAug 8, 2025Break; Fluid/Blood Leak; Difficult to Advance; Break; Fluid/Blood Leak; Difficult to Advance

  THE CUSTOMER STATED THAT DURING AN IMPLANT PROCEDURE (PATIENT INVOLVED), THE PHYSICIAN USED AN MVSD 6 MM DEVICE, WHICH SHOULD BE COMPATIBLE WITH THE ODS III 6F DELIVERY SET. THE DEVICE WAS INSPECTED PRIOR TO USE. HOWEVER, UPON REACHING THE CURVED PART OF THE DELIVERY SET, THE CABLE COULD NOT ADVANCE FURTHER. IT LOST PUSHABILITY AND WAS NO LONGER RESPONSIVE, PREVENTING PROPER DEPLOYMENT. AS A RESULT, PHYSICIAN UPSIZED TO AN ODS III 7F (98US007, LOT; DP-21419), AFTER WHICH THE DEVICE WAS SUCCESSFULLY DEPLOYED. THE PATIENT RECOVERED AND EVENT RESOLVED. ADDITIONALLY, A PART OF THE LOADER CAME OUT OF PLACE WHILE ADVANCING THE DEVICE, WHICH RESULTED IN BLOOD SPILLAGE. THE ISSUE IS RELATED TO THE COMPATIBILITY PROBLEM BETWEEN THE MVSD 6 MM AND ODSIII 6F. CLINICALLY SIGNIFICANT EXTENDED TREATMENT OR PROCEDURE TIME. THE AFFECTED ODSIII WAS DISCARDED BY THE HOSPITAL. PLEASE FIND THE PICTURES ATTACHED AS PROVIDED BY CUSTOMER. THERE WAS A DELAY, LESS THAN 30 MINUTES. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING THE 7F DELIVERY SET. THE PATIENT'S ANATOMY WAS NORMAL, WITH NO ABNORMALITIES OR CHALLENGES NOTED DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22751071 ↗
• MalfunctionJul 15, 2025Loose or Intermittent Connection; Loose or Intermittent Connection

  DURING AN IMPLANTATION PROCEDURE, THE PHYSICIAN WANTED TO INSERT THE ODSIII SHEATH 14F INTO THE FEMORAL VEIN AND DISCOVERED THAT THE CONNECTION BETWEEN THE VALVE AND THE SHEATH WAS NOT TIGHT. THE PHYSICIAN WAS ABLE TO PULL THE VALVE OFF THE SHEATH EASILY. IT WAS THEN SWITCHED TO A NEW ODSIII SHEATH 14F AND THE IMPLANTATION WAS SUCCESSFULLY COMPLETED WITHOUT ANY FURTHER INCIDENTS. THE PATIENT LEFT THE CATH LAB WITHOUT ANY COMPLAINTS AND WAS IN GOOD CONDITION. IT WAS ALSO REPORTED THE VALVE WAS NOT FIRMLY CONNECTED TO THE SHEATH. THERE WAS NO GAP AT VALVE WHEN THE DILATOR WAS INSERTED OR ANY OTHER ANCILLARY DEVICE. THE VALVE HAS DETACHED ITSELF FROM THE SHEATH. NO PICTURES OR VIDEO AVAILABLE AND NO DELAY IN THE PROCEDURE. NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION. NO ANATOMICAL ABNORMALITIES PATIENT WAS A YOUNG SLIM MAN. DEVICE WILL BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22510237 ↗
• MalfunctionJun 24, 2025Break; Device Damaged by Another Device; Break; Device Damaged by Another Device

  THE CUSTOMER REPORTED THAT DURING PATIENT CONTACT (DURING IMPLANTATION PROCESS) THE LOADER'S EXTREMITY DETACHED + SHEATH'S TIP WITH A LITTLE PLASTIC FRAGMENT FOUND DURING THE FLUSHING. I TOOK THE DEFECTIVE PRODUCTS (SHEATH WITH PLASTIC FRAGMENT + LOADER) TO SEND THEM FOR EXPERTISE. THE DEVICE WAS INSPECTED PRIOR TO USE; HOWEVER, IT'S NOTED THERE WAS A DEVIATION DURING THE INSPECTION. THERE WAS NO PRE-EXISTING CONDITION RELEVANT TO THE EVENT. PROCEDURE COMPLETED SUCCESSFULLY. THERE WAS NO OTHER DEVICE USED TO COMPLETE THE PROCEDURE. THE CUSTOMER STATES THE REPORTED ISSUE WAS CLINICALLY SIGNIFICANT EXTENDED TREATMENT OR PROCEDURE TIME AND COULD HAVE BEEN VERY SERIOUS. THE DEVICE WILL BE RETURNED. 24/JUN/2025 CLARIFICATION OF EVENT RECEIVED: THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND NO OTHER DEVICE WAS USED BUT THE PATIENT WAS INVOLVED, SORRY FOR THE MISUNDERSTANDING. WE FOUND A LITTLE BLUE PLASTIC FRAGMENT PROVIDED FROM THE SHEATH DURING THE FLUSHING. YOU HAVE TO CONSIDER 2 DIFFERENT PROBLEMS: THE FIRST ONE WAS THE LITTLE PLASTIC FRAGMENT FROM THE SHEATH FOUND DURING THE FLUSHING, AND THE SECOND ONE WAS THE GLUING PROBLEM CONCERNING THE LOADER. FOR THE FIRST PROBLEM (BLUE PLASTIC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22321745 ↗
• MalfunctionJun 13, 2025Fluid/Blood Leak; Difficult to Flush; Fluid/Blood Leak; Difficult to Flush

  THE CUSTOMER REPORTED THE TYPE OF PROCEDURE: PATENT FORAMEN OVALE (PFO) CLOSURE. THERE WAS A 5-MINUTE DELAY IN THE PROCEDURE. NO PICTURES OR VIDEO BUT IF YOU FLUSH THE LATERAL WAY OF THE SHEATH YOU WILL SEE EASILY THE LEAK THROUGH THE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22201894 ↗
• MalfunctionApr 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT WHEN INSTALLING THE CATHETER CARRYING THE PROBE, THE PROXIMAL PART OF THE VALVE BECOMES DETACHED (NON-BONDING). RISK OF AIR EMBOLISM GAS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21873467 ↗
• InjuryMar 17, 2025Fluid/Blood Leak; Infusion or Flow Problem; Fluid/Blood Leak; Infusion or Flow Problem

  PRIOR TO IMPLANTATION OCCLUDER WAS FLUSHED, LOADED 2X AND ALWAYS FLUSHED WITH WATER TO REMOVE AIR BUBBLES FROM THE DEVICE AND MATERIAL. SHEATH WAS FLUSHED AS WELL AND ONCE PLACED IN THE PATIENT WE ASPIRATED 20ML OF BLOOD TO REMOVE AIR FROM THE SHEATH AFTER DILATOR REMOVAL. THEN LOADER TOGETHER WITH THE OCCLUDER WAS UNDER CONSTANT FLUSH CONNECTED TO THE DELIVERY SHEATH. AFTER THE LEFT SIDE OF THE OCCLUDER WAS DEPLOYED ECG HAS CHANGED AND THE PATIENT FELT CHEST PAIN AND SHORTNESS OF BREATH. AIR EMBOLIE WAS SUSPECTED. AFTER 5-7 MIN ECG WAS AGAIN NORMAL AND THE CHEST PAIN WAS LESS PRESENT IN THE PATIENT. THE DEVICE WAS IMPLANTED, AND THE PATIENT WAS DISCHARGED WITHOUT ANY CONSEQUENCES. DEVICE WAS DISCARDED BY HOSPITAL. CONSEQUENCES TO EVENT: AIR ENTERING INTO VASCULAR SYSTEM & EMBOLISM. (B)(6)2025: CUSTOMER PROVIDED ADDITIONAL DETAILS: PROCEDURE TAKING PLACE WHEN ISSUE WAS FOUND WAS TO CLOSE THE PFO (PATENTED FORAMEN OVALE). IT IS UNKNOWN EXACTLY WHEN THE AIR GOT INTO THE DEVICE BUT IT WAS NOTICED (ECG CHANGED AND PATIENT COMPLAINED ABOUT THE CHEST PAIN AND BREATHING ISSUES) SHORTLY AFTER THE LEFT SIDE OF THE PFO DEVICE WAS DEPLOYED. THERE WAS A SHORT DELAY OF 10-15 MORE MINUTES UNTIL

  Patient problems: Air Embolism

  MAUDE report 21621822 ↗
• InjuryNov 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUMMARY: DEVICE DISLOCATION / EMBOLIZATION. THE EVENT OCCURRED DURING PATIENT CONTACT. CONSEQUENCES OF EVENT: PERCUTANEOUS REMOVAL (MEANS REMOVAL OF KIDNEY STONES). EVENT NOTIFIED TO AUTHORITY. [DESCRIPTION / SEQUENCE OF EVENTS]: PERIVALVULAR REGURGITATION CLOSURE PROCEDURES WERE UNDERTAKEN. A PLD WAS IMPLANTED VIA THE TF APPROACH AND AN ODSIII WAS INSERTED TO IMPLANT A SECOND PLD WHEN THE INITIALLY IMPLANTED PLD BECAME DISLODGED. THE PLD WAS LOCATED IN THE LEFT ATRIUM AND RETRIEVED WITH A SNARE CATHETER. AN ATTEMPT WAS MADE TO RESUME THE PLD IMPLANTATION PROCEDURE, BUT THE PATIENT'S BLOOD PRESSURE DROPPED, AND THE PROCEDURE WAS ABANDONED AND TERMINATED. PATIENT CONDITION RESOLVED. THE DEVICE WAS DISCARDED BY THE HOSPITAL. (B)(6) 2024: TF IS TRANSFEMORAL (TF) AND PLD IS OUR OCCLUTECH PARAVALVULAR LEAK DEVICE. AGAIN, MAY I PLEASE CLARIFY THE REPORTED 98DL010; LOT: DP-21333 IS NOT A COMPLAINT AND HAS NOT BEEN GIVEN ANY COMPLAINT NUMBER FROM US AS WELL. (B)(4) IS ASSIGNED TO THE OCCLUTECH PARAVALVULAR LEAK DEVICE ONLY. PLEASE PROVIDE US ONLY THE BATCH RECORD REVIEW FOR THE MENTIONED ODS III ONLY SINCE THE CUSTOMER CLAIMED FOR ONE. [NOTE]: ALL MEDICAL RECORDS, INCLUDING CTS, ARE NOT AV

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 20745489 ↗
• MalfunctionNov 15, 2024Fluid/Blood Leak; Fluid/Blood Leak

  (B)(6) 2024 DURING DEVICE PREP, FOR CLOSURE OF ATRIAL SEPTAL DEFECT (FASD) IN A PATIENT WITH PULMONARY HYPERTENSION. THE 18MM FENESTRATED ATRIAL SEPTAL DEFECT WAS PULLED BACK IN THE LOADER, AND THE OPERATOR STARTED TO FLUSH TO DE-AIR THE SYSTEM. DESPITE ALL ATTEMPTS, THE LOADER COULD NOT BE DE-AIRED DUE TO AIR ENTERING THE LOADER THROUGH THE PROXIMAL HEMOSTATIC VALVE, WHERE THE PUSHER IS INSERTED. ADDITIONAL ATTEMPTS WERE MADE TO KEEP THE PUSHER STRAIGHT WITH THE LOADER AND THE SALINE BOWL TILTED WITH THE DISTAL END OF THE LOADER SUBMERGED, AS WELL AS HOLDING THE LOADER UPRIGHT WITH THE PUSHER AND LOADER STRAIGHT. THE AIR WAS STILL ENTERING THE LOADER THROUGH THE PROXIMAL HEMOSTATIC VALVE. THE 12F ODSIII SYSTEM WAS ABANDONED, AND AN ODS 12F SYSTEM WAS USED INSTEAD. NO ISSUES OCCURRED WITH THE ODSI SHEATH. THE ISSUE WAS RESOLVED WHEN THE OLDER MODEL ODS L WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A DELAY OF LESS THAN 30 MINUTES. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THERE ARE NO PICTURES, OR IMAGES AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20694484 ↗
• InjurySep 27, 2024Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  WE HAVE A NEW COMPLAINT REGARDING ODSIII ((B)(4)). THE CUSTOMER (B)(6) STATED IN THE INITIAL EMAIL THAT "ODSIII WAS BROKEN (REF: (B)(4); LOT: DP- 19004)". THE PATIENT WAS TREATED FOR AN EMERGENCY IMPLANTATION OF A VSD (VENTRICULAR SEPTAL DEFECT) OCCLUDER AFTER A HEART ATTACK. THE CUSTOMER STATED THAT DURING THE VENTRICULAR SEPTAL DEFECT (VSD) CLOSURE IMPLANTATION PROCEDURE, DIRECTLY WHEN RELEASING THE DEVICE, THE SHEATH CAME APART DURING IMPLANTATION, WHEN PUSHING THROUGH THE OCCLUDER. NO DAMAGE, THE SHEATH COULD BE REPLACED WITH A NEW ONE. THERE IS A DELAY IN THE PROCEDURE OF MORE THAN 40 MINUTES. THERE WAS A MEDICAL INTERVENTION FOR 11. IMPLANTATION OF AN ASD OCCLUDED. FORTUNATELY, THERE WAS NO HARM TO THE PATIENT, THE ENTIRE SYSTEM (SHEATH AND THE LOADED OCCLUDER) COULD BE PULLED OUT AND REPLACED WITH A NEW SHEATH. THE ISSUE RESOLVED BY UPSIZING THE SHEATH. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. SUBMISSION FOR ADMINISTRATIVE PURPOSE AS THERE WAS A DELAY IN THE PROCEDURE OF MORE THAN 40 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20322429 ↗
• MalfunctionJul 26, 2024Break; Difficult to Advance; No Apparent Adverse Event; Break; Difficult to Advance; No Apparent Adverse Event

  PLEASE BE INFORMED THAT TODAY I FACED AN UNPLEASANT SITUATION AT (B)(6) : ASD PATIENT: 9 MONTHS OLD, 6KG ASD MEASURED 9 MM - DEVICE CHOSEN: ASD10 DUE TO TINY PATIENT DIMENSIONS THE DOWNSIZING OF SHEATH WAS SEEN AS A HUGE ADVANTAGE ASD10 PROCEDURE PACK STATED COMPATIBILITY TO 6F ODS III - SHEATH CHOSEN: ODS III 6F FIRST ODS III 6F SHEATH: HARD TO ADVANCE OCCLUDER & FLEXPUSHER CABLE THROUGH LOADER/ SHEATH ASSEMBLY HUB WITH HEMOSTATIC VALVE & SIDE PORT DETACHED FROM SHEATH EXCHANGED TO SECOND ODS III 6F (SAME LOT#): SAME BEHAVIOR NOT ABLE TO ADVANCE OCCLUDER THROUGH SHEATH/ LOADER ASSEMBLY OCCLUDER - GOT STUCK THIRD SHEATH EXCHANGED TO ODS III 7F + ASD10 EXCHANGED DUE TO HIGH FORCES & UNKNOWN DEVICE INTEGRITY - PROCEDURE WAS SUCCESSFULLY COMPLETED DUE TO THE SHEATH EXCHANGES WITH CAREFUL PRODUCT PREPARATION STEPS ACCORDING TO THE IFU THE PROCEDURE WAS DELAYED BY 40 MIN. THANKS TO MY EXCELLENT RELATIONSHIP TO THE ATTENDING PHYSICIAN DR. (B)(6) AND SENIOR CONSULTANT PROF. (B)(6) I WAS ABLE TO DEESCALATE THIS DELICATE SITUATION IN THE CATH LAB. THIS WOULD HAVE BEEN THE LAST CONVINCING CASE BEFORE THE PEDIATRIC DEPARTMENT WOULD HAVE SWITCHED COMPLETELY TO ODS III DUE TO THE DOWNSIZING AR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19837852 ↗

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