ACCESSRAIL Platform (Standard Blade) SB-1000Recalls & reported problems
Maquet Cardiovascular LLC · ACCESSRAIL Platform (Standard Blade) · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00607567700215), received between May 3, 2023 and Mar 8, 2024 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (4 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Jun 28, 2023Class IIOpen, Classified
The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to stabilize and position or may result in the loss of stabilization and positioning of heart, release of device component into the patient, and/or a procedural delay and/or conversion.
Z-2271-2023 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported problems
Device problems
- Mechanical Problem4
- Insufficient Device Problem Information2
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 8, 2024Mechanical Problem; Mechanical Problem
THE HOSPITAL REPORTED THAT DURING PREPARATION FOR A CORONARY ARTERY BYPASS PROCEDURE, ONE OF THE STANDARD BLADES WOULD NOT LOCK INTO PLACE. ISSUE WAS FOUND BEFORE PATIENT WAS IN ROOM. NEW DEVICE AND INSTRUMENT OBTAINED. NO DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18870752 ↗MalfunctionJul 26, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
THE HOSPITAL REPORTED THAT THE SB-1000 STANDARD BLADES (RIGHT) MALFUNCTIONED AND IT WASN'T WORKING PROPER. NO INJURY TO THE PATIENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17396992 ↗MalfunctionJul 26, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
THE HOSPITAL REPORTED THAT THE SB-1000 STANDARD BLADES MALFUNCTIONED AND IT WASN'T WORKING PROPERLY. NO INJURY TO THE PATIENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17396445 ↗MalfunctionMay 19, 2023Mechanical Problem; Mechanical Problem
MalfunctionMay 12, 2023Mechanical Problem; Mechanical Problem
RELATED TO 812290. THE HOSPITAL REPORTED THAT THE STANDARD LEFT BLADES WERE NOT STAYING ON THE UA-5001 RETRACTOR, THE TABS DID NOT SECURE THE BLADES. THERE WAS NO PROCEDURAL DELAY. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO INJURIES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16918132 ↗MalfunctionMay 3, 2023Mechanical Problem; Mechanical Problem
THE HOSPITAL REPORTED THEY WERE HAVING ISSUE WITH BLADES SB-1000 LOCKING ONTO THE ULTIMA ACTIVATOR II REUSABLE DRIVE MECH. THEY USED ANOTHER SB-1000 TO COMPLETE CASE. NO CASE DELAY REPORTED. NO HARM TO PATIENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16861759 ↗
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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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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