Aspirex® S 6F 135cm 80203Recalls & reported problems
Straub Medical AG · The Aspirex® S catheter (gauge 6F; length 135cm) is over-the-wire, single use, percutaneous device for the treatment of occlusions in venous vasculature. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07640142810438), received between Oct 3, 2022 and May 6, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Break1
- Mechanical Jam1
- Physical Resistance/Sticking1
- Retraction Problem1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Extravasation1
- Hematoma1
- No Clinical Signs, Symptoms or Conditions1
- Pain1
- Vascular Dissection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 6, 2024Retraction Problem; Physical Resistance/Sticking; Retraction Problem; Physical Resistance/Sticking
IT WAS REPORTED THAT DURING A THROMBECTOMY AND ATHERECTOMY PROCEDURE IN THE LEFT UPPER ARM FISTULA VIA THE LEFT ARM CEPHALIC VEIN, THE CATHETER ALLEGEDLY ENCOUNTERED RESISTANCE IN THE VEIN AND WHEN ATTEMPTED TO REMOVE IT FROM THE PATIENT, THE WIRE WAS UNABLE TO BE KEPT IN PLACE AS THE CATHETER ALLEGEDLY PREVENTED THE WIRE FROM BEING ADVANCED OR PULLED BACK. IT WAS FURTHER REPORTED THAT THE CATHETER WAS REMOVED WITH THE WIRE ALLEGEDLY BEING STUCK INSIDE OF IT, LOSING WIRE ACCESS. FURTHERMORE, UNDER A VENOGRAM, IT WAS FOUND THAT THERE WAS EXTRAVASATION AND DISSECTION OF THE VESSEL WHERE THE CATHETER WAS OPERATED. REPORTEDLY, COMPRESSION WAS DONE FOR EXTRAVASATION AND TISSUE PLASMINOGEN ACTIVATOR WAS INITIALLY USED TO OPEN THE FISTULA BUT THE FISTULA FAILED TO ACHIEVE THE PATENCY AND WAS LOST. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Patient problems: Extravasation; Vascular Dissection
MAUDE report 19247122 ↗InjuryOct 3, 2022Break; Mechanical Jam; Break; Mechanical Jam
IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE GUIDEWIRE ALLEGEDLY STUCK ON THE CATHETER. IT WAS FURTHER REPORTED THAT THERE WAS ALLEGEDLY SHARDS OF THE DEVICE IN THE SALINE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hematoma; No Clinical Signs, Symptoms or Conditions; Pain
MAUDE report 15526657 ↗
Other Peripheral Mechanical Thrombectomy With Aspiration devices
- Indigo System LITNG12HTORQ115-APenumbra, Inc. · Peripheral Mechanical Thrombectomy With Aspiration4 deaths105 reports
- Indigo System LITNG7XTORQ130-APenumbra, Inc. · Peripheral mechanical thrombectomy with aspiration100 reports
- Indigo System LITNG12XTORQ100-APenumbra, Inc. · Peripheral Mechanical Thrombectomy With Aspiration1 death80 reports
- ClotTriever XL Catheter AS-0235Inari Medical, Inc. · Peripheral Mechanical Thrombectomy With Aspiration1 recall9 deaths20 reports
- Indigo System LITNGBT7TQ130-APenumbra, Inc. · Peripheral Mechanical Thrombectomy With Aspiration46 reports
- Indigo System LITNG12HTORQ100-APenumbra, Inc. · Peripheral Mechanical Thrombectomy With Aspiration1 death46 reports
- Triever 24 22-101Inari Medical, Inc. · Peripheral Mechanical Thrombectomy With Aspiration20 deaths34 reports
- ClotTriever Catheter, 16 mm 40-102Inari Medical, Inc. · Peripheral Mechanical Thrombectomy With Aspiration11 deaths27 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page