CPS Locator 3D, Medium Delivery Catheter DS2C200-42Recalls & reported problems
Centerpoint Systems LLC · Delivery Catheter and dilator · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00810024670123), received between Jun 18, 2024 and Feb 25, 2025 — classified as 2 injuries, 1 malfunction.
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
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Device Contaminated During Manufacture or Shipping1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Cardiac Perforation1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryFeb 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CPS LOCATOR SHEATH PERFORATION THROUGH THE RIGHT VENTRICLE APEX.
Patient problems: Cardiac Perforation
MAUDE report 21462149 ↗InjurySep 27, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
WHEN THE DOCTOR INSERTED THE GUIDING DILATOR, THERE WAS RESISTANCE AND A MESH-LIKE TISSUE WAS ATTACHED TO THE TIP OF THE DILATOR. DOCTOR'S OPINION: PRODUCT DEFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20325336 ↗MalfunctionJun 18, 2024Break; Break
RIGHT SIDED DUAL CHAMBER PACEMAKER WITH LEFT BUNDLE BRANCH AREA PACING. ONCE ACCESS WAS OBTAINED THE PHYSICIAN SHAPED THE CPS LOCATOR WITH THE DILATOR INSIDE. HE INTRODUCED THE CPS LOCATOR WITH THE DILATOR, THEN REMOVED THE DILATOR AND WENT IN WITH THE LEAD UNDER FLUORO AND NOTICED THAT THE CPS LOCATOR WAS BROKEN OFF INTO THE BODY. THE PHYSICIAN THINKS THAT SINCE THE TURNE OF SVC WAS ALMOST 110 DEGREES THAT WHEN THE INTRODUCER WAS REMOVED THE CPS LOCATOR BROKE. THERE WAS ABOUT 5 INCHES OF CPS LOCATOR LEFT IN THE BODY THAT WAS REMOVED WITH A SNARE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19563563 ↗
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- WATCHMAN™ TruSeal™ Access System M635TU70020Boston Scientific Corporation · Catheter, percutaneous1 recall11 deaths217 reports
- Lantern Delivery Catheter PXSLIMLAN135T45Penumbra, Inc. · CATHETER, PERCUTANEOUS220 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.
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