MEDTRONIC CRYOCATH LP

FDA MAUDE device safety record · 2009–2026

What the Data Shows About MEDTRONIC CRYOCATH LP

MEDTRONIC CRYOCATH LP is associated with 8,872 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2009 through 2026. Of the total, 240 are coded as death reports and 4,260 as injury reports, with the remainder classified as malfunctions or other event types. These counts reflect reports submitted to the FDA by manufacturers, healthcare facilities, and patients — they are raw signal, not adjudicated safety findings, and higher-volume manufacturers or older product portfolios naturally generate larger raw counts.

The reports span 17 distinct device types attributed to this manufacturer in MAUDE, which means any safety read for MEDTRONIC CRYOCATH LP should be reviewed at the device-family level rather than company-wide. Across those devices, 3 distinct event types appear in the record, led by Malfunction at 4,372 reports (49.3% of total). Patient-outcome categorizations are reported across 13 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 17 years of MAUDE data, with the peak single-year volume reaching 1,244 reports — trend shape can reflect shifts in device sales, FDA reporting requirements, or post-market recall activity as much as intrinsic device performance. The MAUDE system is one input among many in FDA post-market surveillance and does not draw safety conclusions from individual submissions. All figures reflect the openFDA snapshot refreshed on , and nothing on this page is medical or regulatory advice — consult a qualified clinician or the FDA for current safety communications.

8,872
Total Reports
240
Death Reports
4,260
Injury Reports
17
Device Types

Event Types

Malfunction 4,372 (49.3%)
Injury 4,260 (48.0%)
Death 240 (2.7%)

Patient Outcomes

4,323 (35.9%)
R 1,687 (14.0%)
Hospitalization 1,497 (12.4%)
Other 1,151 (9.6%)
L 1,049 (8.7%)
Required Intervention 1,010 (8.4%)
Life Threatening 622 (5.2%)
H 362 (3.0%)
Death 225 (1.9%)
O 57 (0.5%)
Disability 34 (0.3%)
D 16 (0.1%)
S 14 (0.1%)

Yearly Trend

09
2009: 2
11
2011: 218
12
2012: 147
13
2013: 214
14
2014: 235
15
2015: 479
16
2016: 554
17
2017: 719
18
2018: 962
19
2019: 865
20
2020: 677
21
2021: 599
22
2022: 520
23
2023: 573
24
2024: 684
25
2025: 1,244
26
2026: 180

Data Source

FDA Manufacturer and User Facility Device Experience (MAUDE) database via the openFDA API. Reports are submitted by manufacturers, healthcare facilities, and patients. Report counts do not indicate a manufacturer's products are unsafe — higher-volume manufacturers naturally generate more reports.